Clearance Summary
COMFEEL:ALGINATE DRESSING received FDA 510(k) clearance under submission number K953497, sponsored by Coloplast A/S. 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 1995-09-29.
- Submission: K953497
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 1995-09-29
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.