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De Novo DEN080011
- Device
- SNAP WOUND CARE DEVICE
- Contact
- janice m hogan
- De Novo number
- DEN080011
- Product code
- OKO
- Regulation
- 878.4683
- Classification name
- negative pressure wound therapy non-powered suction apparatus
- Decision
- granted (DENG)
- Decision date
- 2009-08-07
- Date received
- 2008-11-03
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OKO
- Device name
- Negative Pressure Wound Therapy Non-Powered Suction Apparatus
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4683
- Implant
- N
- Life sustain/support
- N