K-number	K223249
Device name	Pro-Tx Endorectal Balloon (PROT-25)
Applicant	Dxtx Medical, Inc.
Product code	PCT
Device class	Class II
Decision date	Feb 10, 2023
Decision	Substantially Equivalent
Regulation	892.5720

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Source

View the full FDA submission: accessdata.fda.gov

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Pro-Tx Endorectal Balloon (PROT-25)

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