Clearance Summary
PLASTIC ADHESIVE BANDAGE received FDA 510(k) clearance under submission number K802764, sponsored by Dyn-A-Med Products. 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 1980-11-24.
- Submission: K802764
- Applicant / Sponsor: Dyn-A-Med Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1980-11-24
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.