Clearance Summary
SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM received FDA 510(k) clearance under submission number K962789, sponsored by Smith & Nephew Endoscopy, 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 1996-08-14.
- Submission: K962789
- Applicant / Sponsor: Smith & Nephew Endoscopy, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1996-08-14
Classification & Regulation
This clearance is catalogued under FDA product code GEY and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.