Clearance Summary
STEREOMED CAMERA received FDA 510(k) clearance under submission number K823534, sponsored by Diseases of the Skin Clinic, P.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1982-12-15.
- Submission: K823534
- Applicant / Sponsor: Diseases of the Skin Clinic, P.A.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 1982-12-15
Classification & Regulation
This clearance is catalogued under FDA product code FTT and 21 CFR 878.4160, within the General, Plastic Surgery review panel as a Class I device.