Clearance Summary
ULTRAFERA WOUND DRESSING received FDA 510(k) clearance under submission number K964614, sponsored by American White Cross, 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 1997-02-06.
- Submission: K964614
- Applicant / Sponsor: American White Cross, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 1997-02-06
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.