Clearance Summary
GUARDIAN GEL, SURGEON'S GLOVING CREAM received FDA 510(k) clearance under submission number K910687, sponsored by Guardian Angel Products, 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 1991-10-11.
- Submission: K910687
- Applicant / Sponsor: Guardian Angel Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4470
- Decision date: 1991-10-11
Classification & Regulation
This clearance is catalogued under FDA product code KGQ and 21 CFR 878.4470, within the General, Plastic Surgery review panel as a Class I device.