K-number	K884578
Device name	POLARIX 2 AND POLARIX 2E
Applicant	Dyna-Med
Product code	JAA
Device class	Class II
Decision date	Feb 9, 1989
Decision	Substantially Equivalent
Regulation	892.1650

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View the full FDA submission: accessdata.fda.gov

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POLARIX 2 AND POLARIX 2E

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