Clearance Summary
AQUACEL HYDROFIBER WOUND DRESSING received FDA 510(k) clearance under submission number K982116, sponsored by Convatec, A Bristol-Myers Squibb Co.. 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 1998-09-08.
- Submission: K982116
- Applicant / Sponsor: Convatec, A Bristol-Myers Squibb Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 1998-09-08
Classification & Regulation
This clearance is catalogued under FDA product code KMF and 21 CFR 880.5090, within the General Hospital review panel as a Class I device.