Clearance Summary
PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR received FDA 510(k) clearance under submission number K930589, 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 1993-12-17.
- Submission: K930589
- Applicant / Sponsor: Davis & Geck, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4830
- Decision date: 1993-12-17
Classification & Regulation
This clearance is catalogued under FDA product code GAL and 21 CFR 878.4830, within the General, Plastic Surgery review panel as a Class II device.