510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K843525Substantially Equivalent

Suture Tray

Pro-Lab, Inc., Round Rock TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843525 is the FDA 510(k) clearance record for SUTURE 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 K843525.

Clearance record

Decision date
Received
(59 days to decision)
Review panel
Unknown
Applicant
Pro-Lab, Inc. P.O. Box 503, Round Rock TX
Third party review
No