Clearance Summary
G WRAP received FDA 510(k) clearance under submission number K780294, sponsored by Cel-Fibe. 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 1978-03-28.
- Submission: K780294
- Applicant / Sponsor: Cel-Fibe
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 1978-03-28
Classification & Regulation
This clearance is catalogued under FDA product code FRG and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.