510(k) K823534
K823534 is an FDA 510(k) premarket notification submitted by Diseases of the Skin Clinic, P.A. for the device "STEREOMED CAMERA". The FDA issued a decision of Substantially Equivalent on December 15, 1982. The device falls under product code FTT (Camera, Still, Surgical), a Class I device regulated under 21 CFR 878.4160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1982
- Date Received
- November 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Still, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type