Clearance Summary
SURGILON, DERMALON, & OPHTHALON received FDA 510(k) clearance under submission number K981582, sponsored by Davis & Geck, Inc.. 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 1998-07-13.
- Submission: K981582
- Applicant / Sponsor: Davis & Geck, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5020
- Decision date: 1998-07-13
Classification & Regulation
This clearance is catalogued under FDA product code GAR and 21 CFR 878.5020, within the General, Plastic Surgery review panel as a Class II device.