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
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K844597Substantially Equivalent

Miscellaneous General Surgical Custom Kit

Xanmed Corp., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844597 is the FDA 510(k) clearance record for MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT, cleared for Xanmed Corp. on . FDA records list 9 510(k) clearances for Xanmed Corp., from to . As of , FDA records show no recalls naming K844597.

Clearance record

Decision date
Received
(133 days to decision)
Review panel
Unknown
Applicant
Xanmed Corp. 815 Connecticut Ave. Nw, Washington DC
Third party review
No