510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K828671Substantially Equivalent

Uvatec Suntamed 4000 and 2000

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

K828671 is the FDA 510(k) clearance record for UVATEC SUNTAMED 4000 AND 2000, 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 K828671.

Clearance record

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