510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861878Substantially Equivalent for Some Indications

Byron Suction Tips

Byron Medical, Tucson AZ / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K861878 is the FDA 510(k) clearance record for BYRON SUCTION TIPS, cleared for Byron Medical on . FDA records list 27 510(k) clearances for Byron Medical, from to . As of , FDA records show no recalls naming K861878.

Clearance record

Decision date
Received
(47 days to decision)
Review panel
Unknown
Applicant
Byron Medical 3280 E. Hemisphere Loop, Tucson AZ
Third party review
No