510(k) K828670
K828670 is an FDA 510(k) premarket notification submitted by Solitec GmbH for the device "UVATEC SUNTAMED 400". The FDA issued a decision of Substantially Equivalent on January 17, 1983. Solitec GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1983
- Date Received
- November 30, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No