K-number	K132386
Device name	TOTALSHIELD SURGICAL HELMET SYSTEM
Applicant	Zimmer, Inc.
Product code	FYA
Device class	Class II
Decision date	Dec 23, 2013
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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TOTALSHIELD SURGICAL HELMET SYSTEM

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