Clearance Summary
SUTUREMATE received FDA 510(k) clearance under submission number K926126, sponsored by Surgical Safety 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 1993-05-19.
- Submission: K926126
- Applicant / Sponsor: Surgical Safety Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1993-05-19
Classification & Regulation
This clearance is catalogued under FDA product code MDM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.