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
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K827454Substantially Equivalent

Unknown

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

K827454 is the FDA 510(k) clearance record for UNKNOWN, cleared for Ote Biomedica on . FDA records list 3 510(k) clearances for Ote Biomedica, from to . As of , FDA records show no recalls naming K827454.

Clearance record

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