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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K771843Substantially Equivalent

Wetting Agents

Gamma Enterprises, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771843 is the FDA 510(k) clearance record for WETTING AGENTS, cleared for Gamma Enterprises, Inc. on . FDA records list 23 510(k) clearances for Gamma Enterprises, Inc., from to . As of , FDA records show no recalls naming K771843.

Clearance record

Decision date
Received
(62 days to decision)
Review panel
Unknown
Applicant
Gamma Enterprises, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No