K-number	K150151
Device name	SmartGownTM surgical gown
Applicant	Cardinal Health 200, Inc.
Product code	FYA
Device class	Class II
Decision date	May 21, 2015
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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SmartGownTM surgical gown

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