K-number	K192194
Device name	TotalShield II Surgical Helmet System
Applicant	Zimmer Surgical, Inc.
Product code	FYA
Device class	Class II
Decision date	Oct 15, 2019
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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TotalShield II Surgical Helmet System

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