Hello Anon,
If the product has been cleared under the 510(k) process - meaning the 510(k) Clearance Letter is received - then there is nothing you need to do or can do. When a 510(k) is cleared, basically it is "in stone" meaning nothing will get changed. If you used a second company to make the submission, indeed their name will show up on the clearance letter, but at that point it is not really important. What is important is the contact information for the company in the FURLS database is correct, see next point.
What you should make sure is the information contained in the Establishment Registration and Medical Device Listing in the FURLS system is current and correct. If the contact person at the company changes, make sure this is current in the Establishment Registration. If the product information such as the device name changes, make sure this is current in the Medical Device Listing.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 31-May-2023 08:05
From: Anonymous Member
Subject: 510K change of official correspondent
This message was posted by a user wishing to remain anonymous
Hello Experts,
I am looking to see how I can change correspondent and official correspondent information for a recently cleared 510K product.
Background: we are the manufacturer and are identified as such, submission performed by 2nd company. Currently, the correspondent is the 2nd company with their information there and us as the applicant and manufacturer.
Thank you for any guidance!