510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842459Substantially Equivalent

Site Gills Style I/a Handpiece

Chiron Vision Corp., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842459 is the FDA 510(k) clearance record for SITE GILLS STYLE I/A HANDPIECE, cleared for Chiron Vision Corp. on . FDA records list 34 510(k) clearances for Chiron Vision Corp., from to . As of , FDA records show no recalls naming K842459.

Clearance record

Decision date
Received
(54 days to decision)
Review panel
Unknown
Applicant
Chiron Vision Corp. 9342 Jeronimo Rd., Irvine CA
Third party review
No