PROSTATE IMMOBILIZER RECTAL BALLOON— 510(k) DEN130036

Unknown

Radiadyne

FDA 510(k) clearance DEN130036 for PROSTATE IMMOBILIZER RECTAL BALLOON, Unknown on 2014-01-28. Applicant: Radiadyne. Device class: 2.

Clearance details

Applicant: Radiadyne
Product code: Code PCT
Device class: Class 2
Regulation: 21 CFR 892.5720
Advisory panel: Radiology
Date received: 2013-07-15
Decision date: 2014-01-28
Decision: Unknown
Clearance type: Direct
Location: Washington, DC, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.