Clearance Summary
INCUBATOR CAPE received FDA 510(k) clearance under submission number K040794, sponsored by Wrapped IN Comfort. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2004-06-10.
- Submission: K040794
- Applicant / Sponsor: Wrapped IN Comfort
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2004-06-10
Classification & Regulation
This clearance is catalogued under FDA product code MMP and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.