K-number	K991137
Device name	ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
Applicant	Minntech Corp.
Product code	DTR
Device class	Class II
Decision date	Jun 8, 2000
Decision	Substantially Equivalent
Regulation	870.4240

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View the full FDA submission: accessdata.fda.gov

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ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER

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