Clearance Summary
COMFOR FOAM LIMB HOLDERS- SINGLE STRAP received FDA 510(k) clearance under submission number K963462, sponsored by Bird & Cronin, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1996-11-21.
- Submission: K963462
- Applicant / Sponsor: Bird & Cronin, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6760
- Decision date: 1996-11-21
Classification & Regulation
This clearance is catalogued under FDA product code FMQ and 21 CFR 880.6760, within the General Hospital review panel as a Class I device.