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
K822804Substantially Equivalent

Operating Room Procedural Pack

Adicon, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822804 is the FDA 510(k) clearance record for OPERATING ROOM PROCEDURAL PACK, cleared for Adicon on . FDA records list one 510(k) clearance for Adicon. As of , FDA records show no recalls naming K822804.

Clearance record

Decision date
Received
(102 days to decision)
Review panel
Unknown
Applicant
Adicon 4221 Richmond Rd., NW, Walker MI
Third party review
No