Clearance Summary
COMB-18 WOUND DRESSING received FDA 510(k) clearance under submission number K936193, sponsored by Vsc Health Care Products. 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 1994-04-07.
- Submission: K936193
- Applicant / Sponsor: Vsc Health Care Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 1994-04-07
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.