510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833997Substantially Equivalent

Co-Set

American Edwards Laboratories, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833997 is the FDA 510(k) clearance record for CO-SET, cleared for American Edwards Laboratories on . FDA records list 89 510(k) clearances for American Edwards Laboratories, from to . As of , FDA records show no recalls naming K833997.

Clearance record

Decision date
Received
(148 days to decision)
Review panel
Unknown
Applicant
American Edwards Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No