Bhagya,
This does not exist. In fact, the 510(k) database is
not update with new owners or different companies for the products. When a 510(k) is cleared, the information in the database is essentially written in "stone" meaning it is not changed. The only way you can find the current owner of a product is from the 510(k) database, get the Product Code the device was cleared. In most cases ... this should still be the same in the device listing database. In the medical device listing, FURLS, you can search on the Product Code, get the product name, and then click to see who the current manufacturer or owner. This may not always be the case because sometimes when companies buy a product (and thus the 510(k)) they may often change the product name - so it may not always be available.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Nov-2019 04:42
From: Bhagya Munagoti
Subject: 510k Transfer
I am looking for the list of changed ownership and also if there is any database / source where manufacturers are willing to transfer their 510(k) ownership?
I am sorry if I not made myself clear.
Thanks,
Bhagya
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Bhagya Munagoti
QA Manager & Regulatory Lead
Cranleigh
United Kingdom
Original Message:
Sent: 12-Nov-2019 21:17
From: Melissa Walker
Subject: 510k Transfer
Can you clarify the terminology? Are you looking for a list of 510(k)s that have changed ownership? Or something else?
Thanks!
Melissa
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Melissa Walker RAC
President & CTO
St Louis MO
United States
Original Message:
Sent: 12-Nov-2019 03:27
From: Bhagya Munagoti
Subject: 510k Transfer
Can any one advise if there is any database to find 510k Transfers and Transferers list (market)?
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Bhagya Munagoti
QA Manager & Regulatory Lead
Cranleigh
United Kingdom
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