Clearance Summary
BOUFFANT CAP received FDA 510(k) clearance under submission number K953878, sponsored by American Threshold Industries, 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 1996-01-05.
- Submission: K953878
- Applicant / Sponsor: American Threshold Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1996-01-05
Classification & Regulation
This clearance is catalogued under FDA product code FYF and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.