K-number	K133554
Device name	SURGICAL LIGHT HANDLE COVER
Applicant	Microtek Medical, Inc. an Ecolab Company
Product code	FTA
Device class	Class II
Decision date	Apr 8, 2014
Decision	Substantially Equivalent
Regulation	878.4580

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Source

View the full FDA submission: accessdata.fda.gov

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SURGICAL LIGHT HANDLE COVER

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