K-number	K101689
Device name	EMM EQUIPMENT COVER-POLYTHYLENE
Applicant	Exact Medical Manufacturing, Inc.
Product code	KKX
Device class	Class II
Decision date	Sep 20, 2010
Decision	Substantially Equivalent
Regulation	878.4370

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Source

View the full FDA submission: accessdata.fda.gov

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EMM EQUIPMENT COVER-POLYTHYLENE

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