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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K837278Substantially Equivalent

Uwe Sun Stream Uwe Bermuda Uwe Super Nova and Uwe Bronzarette

Unterwasser-Electric GmbH, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837278 is the FDA 510(k) clearance record for UWE SUN STREAM UWE BERMUDA UWE SUPER NOVA AND UWE BRONZARETTE, cleared for Unterwasser-Electric GmbH on . FDA records list one 510(k) clearance for Unterwasser-Electric GmbH. As of , FDA records show no recalls naming K837278.

Clearance record

Decision date
Received
(38 days to decision)
Review panel
Unknown
Applicant
Unterwasser-Electric GmbH 4221 Richmond Rd., NW, Walker MI
Third party review
No