Clearance Summary
PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE received FDA 510(k) clearance under submission number K881426, sponsored by Laboratoire Pan-Pra. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-11-10.
- Submission: K881426
- Applicant / Sponsor: Laboratoire Pan-Pra
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 1988-11-10
Classification & Regulation
This clearance is catalogued under FDA product code NAD and 21 CFR 878.4020, within the General, Plastic Surgery review panel as a Class I device.