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De Novo DEN130016
- Device
- XSTAT
- Contact
- john j smith
- De Novo number
- DEN130016
- Product code
- PGZ
- Regulation
- 878.4452
- Classification name
- non-absorbable, expandable, hemostatic sponge for temporary internal use
- Decision
- granted (DENG)
- Decision date
- 2014-04-03
- Date received
- 2013-01-30
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- PGZ
- Device name
- Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4452
- Implant
- N
- Life sustain/support
- N