510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850072Substantially Equivalent

Custom Open Heart Tray

Pro-Lab, Inc., Birmingham AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850072 is the FDA 510(k) clearance record for CUSTOM OPEN HEART TRAY, cleared for Pro-Lab, Inc. on . FDA records list 27 510(k) clearances for Pro-Lab, Inc., from to . As of , FDA records show no recalls naming K850072.

Clearance record

Decision date
Received
(65 days to decision)
Review panel
Unknown
Applicant
Pro-Lab, Inc. Post Office Box 11276, Birmingham AL
Third party review
No