Clearance Summary
SNAP WOUND CARE DEVICE received FDA 510(k) clearance under submission number DEN080011, sponsored by Spiracur, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-08-07.
- Submission: DEN080011
- Applicant / Sponsor: Spiracur, Inc.
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4683
- Decision date: 2009-08-07
Classification & Regulation
This clearance is catalogued under FDA product code OKO and 21 CFR 878.4683, within the General, Plastic Surgery review panel as a Class II device.