Clearance Summary
SOF-BAND HIGH STRETCH BANDAGES received FDA 510(k) clearance under submission number K810137, sponsored by Johnson & Johnson Professionals, 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 1981-02-17.
- Submission: K810137
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5075
- Decision date: 1981-02-17
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.