K-number	K923538
Device name	MON-A-THERM FOLEY KIT
Applicant	Mallinckrodt Medical
Product code	FCM
Device class	Class II
Decision date	May 27, 1993
Decision	Substantially Equivalent — Kit Device
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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MON-A-THERM FOLEY KIT

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