FDA Clone Howard
| Tracking # |
2022-6542 FDA22086329 |
| Submitted | Sept. 9, 2022 |
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Communications
From: Daniel Boguslaw
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
A duplicate copy of FDA FOIA request # 2022-3443 filed on 05/13/2022 by Essenlix Corporation.
The contents of this request were for "510(K) Number: K200828 Device Name: Athelas Home Decision Date: 03/22/2022 510(k) Number: K181288 Device Name: Athelas One Decision Date: 11/05/2018"
The requested documents will be made available to the general public, and this request is not being made for commercial purposes.
In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.
Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.
Sincerely,
Daniel Boguslaw
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA22086329
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.
From: Food and Drug Administration
Control number: 2022-6542
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail
From: Food and Drug Administration
Dear Requester,
Please find attached the records responsive to your request 2022-6542 regarding previously released records under FOIA request 2022-3443. You will only be receiving the original request letter as the request is still open with the office handling the request and no records have been sent. Please check the close log for FOIAs that have been closed at FDA FOIA Logs | FDA<https://www.fda.gov/regulatory-information/freedom-information/fda-foia-logs>.
The following charges may be included in a monthly invoice:
Reproduction: $0.00 Search: $0.00 Review: $0.00 Certification: $0.00 CD: $0.00 TOTAL: $0.00.
DO NOT SEND ANY PAYMENT UNTIL YOU RECEIVE AN INVOICE
Please contact me if you have questions about your request. You may also contact the FDA FOIA Public Liaison for assistance at: Office of the Executive Secretariat, US Food & Drug Administration, 5630 Fishers Lane, Room 1050, Rockville, MD 20857, E-mail: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>.
Thank you,
Wilson M. Russ
Government Information Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8981
wilson.russ@fda.hhs.gov<mailto:wilson.russ@fda.hhs.gov>
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