Clearance Summary
HEEL GARD received FDA 510(k) clearance under submission number K790954, sponsored by Fem-Gard, 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 1979-06-20.
- Submission: K790954
- Applicant / Sponsor: Fem-Gard, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6140
- Decision date: 1979-06-20
Classification & Regulation
This clearance is catalogued under FDA product code FRK and 21 CFR 880.6140, within the General Hospital review panel as a Class I device.