Clearance Summary
MORGAN SUTURE-DRILL received FDA 510(k) clearance under submission number K853376, sponsored by Bowen & Company, 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 1985-11-13.
- Submission: K853376
- Applicant / Sponsor: Bowen & Company, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1985-11-13
Classification & Regulation
This clearance is catalogued under FDA product code HWE and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.