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De Novo DEN130036
- Device
- PROSTATE IMMOBILIZER RECTAL BALLOON
- Contact
- mark a heller
- De Novo number
- DEN130036
- Product code
- PCT
- Regulation
- 892.5720
- Classification name
- prostate immobilizer rectal balloon
- Decision
- granted (DENG)
- Decision date
- 2014-01-28
- Date received
- 2013-07-15
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- PCT
- Device name
- Prostate Immobilizer Rectal Balloon
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.5720
- Implant
- N
- Life sustain/support
- N