K-number	K112408
Device name	POLY-CHEM 90 ISE MODULE
Applicant	Polymedco, Inc.
Product code	CEM
Device class	Class II
Decision date	Nov 4, 2011
Decision	Substantially Equivalent
Regulation	862.1600

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View the full FDA submission: accessdata.fda.gov

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POLY-CHEM 90 ISE MODULE

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