PROSTATE IMMOBILIZER RECTAL BALLOON
FDA 510(k) clearance DEN130036 · decided 2014-01-28
Clearance details
- K-number
- DEN130036
- Device name
- PROSTATE IMMOBILIZER RECTAL BALLOON
- Applicant
- Radiadyne
- Decision
- Unknown
- Date received
- 2013-07-15
- Decision date
- 2014-01-28
- Days to decision
- 197 days
- Clearance type
- Direct
- Product code
- PCT
- Device class
- 2
- Regulation number
- 892.5720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.