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De Novo DEN130004
- Device
- MOERAE SURGICAL MARKING PEN
- Contact
- robert j chin
- De Novo number
- DEN130004
- Product code
- PDW
- Regulation
- 878.4670
- Classification name
- internal tissue marker
- Decision
- granted (DENG)
- Decision date
- 2014-12-18
- Date received
- 2013-05-06
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PDW
- Device name
- Internal Tissue Marker
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4670
- Implant
- N
- Life sustain/support
- N