The following data is part of a De Novo classification by Spiracur, Inc. with the FDA for Snap Wound Care Device.
| DeNovo ID | DEN080011 |
| Device Name: | SNAP WOUND CARE DEVICE |
| Classification | Negative Pressure Wound Therapy Non-powered Suction Apparatus |
| Applicant | SPIRACUR, INC. 1835 Market Street suite 2820 Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Product Code | OKO |
| CFR Regulation Number | 878.4683 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K081406 |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Post-NSE |
| Date Received | 2008-11-03 |
| Decision Date | 2009-08-07 |
| Reclassification Order: | Reclassification Order |