Clearance Summary
FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) received FDA 510(k) clearance under submission number K971744, sponsored by Berkley Medical Resources, 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 1997-07-28.
- Submission: K971744
- Applicant / Sponsor: Berkley Medical Resources, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1997-07-28
Classification & Regulation
This clearance is catalogued under FDA product code FXX and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.