Clearance Summary
BANDAGE, TRIANGULAR NO. 8068 received FDA 510(k) clearance under submission number K760250, sponsored by Johnson & Johnson Professionals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1976-07-26.
- Submission: K760250
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3640
- Decision date: 1976-07-26
Classification & Regulation
This clearance is catalogued under FDA product code ILI and 21 CFR 890.3640, within the Physical Medicine review panel as a Class I device.