K-number	K180478
Device name	RectalPro 75 Endorectal Balloon
Applicant	Qlrad International , Ltd.
Product code	PCT
Device class	Class II
Decision date	Nov 13, 2018
Decision	Substantially Equivalent
Regulation	892.5720

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Source

View the full FDA submission: accessdata.fda.gov

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RectalPro 75 Endorectal Balloon

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