Clearance Summary
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE received FDA 510(k) clearance under submission number K905482, sponsored by Pfizer Hospital Products Group, 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 1991-03-14.
- Submission: K905482
- Applicant / Sponsor: Pfizer Hospital Products Group, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4493
- Decision date: 1991-03-14
Classification & Regulation
This clearance is catalogued under FDA product code GAM and 21 CFR 878.4493, within the General, Plastic Surgery review panel as a Class II device.