Clearance Summary
BAND-AID(TM) BRAND ADHESIVE BANDAGE received FDA 510(k) clearance under submission number K940536, sponsored by Johnson & Johnson Consumer Products, 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 1994-10-03.
- Submission: K940536
- Applicant / Sponsor: Johnson & Johnson Consumer Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1994-10-03
Classification & Regulation
This clearance is catalogued under FDA product code KGX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.