Clearance Summary
ORTHO WRAP received FDA 510(k) clearance under submission number K830622, sponsored by Fast Wrap Co., 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 1983-06-20.
- Submission: K830622
- Applicant / Sponsor: Fast Wrap Co., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5075
- Decision date: 1983-06-20
Classification & Regulation
This clearance is catalogued under FDA product code FQM and 21 CFR 880.5075, within the General Hospital review panel as a Class I device.