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De Novo DEN160012
- Device
- D2 Dressing
- Contact
- sheila k. wallin
- De Novo number
- DEN160012
- Product code
- POD
- Regulation
- 878.4454
- Classification name
- temporary, internal use hemostatic
- Decision
- granted (DENG)
- Decision date
- 2017-06-30
- Date received
- 2016-03-16
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- POD
- Device name
- Temporary, Internal Use Hemostatic
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4454
- Implant
- N
- Life sustain/support
- Y