510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K823136Substantially Equivalent

Oral Sponge

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

K823136 is the FDA 510(k) clearance record for ORAL SPONGE, cleared for Amisplint on . FDA records list one 510(k) clearance for Amisplint. As of , FDA records show no recalls naming K823136.

Clearance record

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