Clearance Summary
PRODEK received FDA 510(k) clearance under submission number K953609, sponsored by Sutures , Ltd.. 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 1996-01-31.
- Submission: K953609
- Applicant / Sponsor: Sutures , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5010
- Decision date: 1996-01-31
Classification & Regulation
This clearance is catalogued under FDA product code GAW and 21 CFR 878.5010, within the General, Plastic Surgery review panel as a Class II device.