Clearance Summary
CUTICOVER SKIN BARRIER DEVICE received FDA 510(k) clearance under submission number K042955, sponsored by D & D Holdings, LLC. 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 2006-06-19.
- Submission: K042955
- Applicant / Sponsor: D & D Holdings, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 2006-06-19
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.