Clearance Summary
STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES received FDA 510(k) clearance under submission number K914937, sponsored by Kerma Medical Products, 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 1991-12-04.
- Submission: K914937
- Applicant / Sponsor: Kerma Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4014
- Decision date: 1991-12-04
Classification & Regulation
This clearance is catalogued under FDA product code NAB and 21 CFR 878.4014, within the General, Plastic Surgery review panel as a Class I device.