Clearance Summary
PRIMED SHOE COVERS, PRIMED HEAD COVERS received FDA 510(k) clearance under submission number K971076, sponsored by Primeline 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 1998-01-13.
- Submission: K971076
- Applicant / Sponsor: Primeline Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1998-01-13
Classification & Regulation
This clearance is catalogued under FDA product code FXP and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.