Clearance Summary
ORLON NONABSORABLE SURGICAL SUTURE USP received FDA 510(k) clearance under submission number K030177, sponsored by Sri Orion Pharmaceuticals & Sutures. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2003-07-21.
- Submission: K030177
- Applicant / Sponsor: Sri Orion Pharmaceuticals & Sutures
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5020
- Decision date: 2003-07-21
Classification & Regulation
This clearance is catalogued under FDA product code GAR and 21 CFR 878.5020, within the General, Plastic Surgery review panel as a Class II device.