Clearance Summary
COMFEEL TRANSPARENT DRESSING received FDA 510(k) clearance under submission number K894916, 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 1989-09-26.
- Submission: K894916
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1989-09-26
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.