Clearance Summary
ADHESIVE BANDAGES WITH OTC DRUG received FDA 510(k) clearance under submission number K943314, 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 1996-01-17.
- Submission: K943314
- 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: 1996-01-17
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.