K-number	DEN130036
Device name	PROSTATE IMMOBILIZER RECTAL BALLOON
Applicant	Radiadyne
Product code	PCT
Device class	Class II
Decision date	Jan 28, 2014
Decision	Not Substantially Equivalent
Regulation	892.5720

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Source

View the full FDA submission: accessdata.fda.gov

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PROSTATE IMMOBILIZER RECTAL BALLOON

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