510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851109Substantially Equivalent

Volkman Retractor 704-8520 Pcs. Blunt-4 Prong Ss42

The Huxley Instrument Corp., Penn Yan NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851109 is the FDA 510(k) clearance record for VOLKMAN RETRACTOR 704-8520 PCS. BLUNT-4 PRONG SS42, cleared for The Huxley Instrument Corp. on . FDA records list 53 510(k) clearances for The Huxley Instrument Corp., from to . As of , FDA records show no recalls naming K851109.

Clearance record

Decision date
Received
(37 days to decision)
Review panel
Unknown
Applicant
The Huxley Instrument Corp. 215 Main St., Penn Yan NY
Third party review
No