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
SUBSCRIBE / SIGN IN
K828670Substantially Equivalent

Uvatec Suntamed 400

Solitec GmbH, Planegg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K828670 is the FDA 510(k) clearance record for UVATEC SUNTAMED 400, cleared for Solitec GmbH on . FDA records list 3 510(k) clearances for Solitec GmbH, from to . As of , FDA records show no recalls naming K828670.

Clearance record

Decision date
Received
(48 days to decision)
Review panel
Unknown
Applicant
Solitec GmbH Fraunhoferstrasse 5, Planegg, DE
Third party review
No