K-number	K970814
Device name	NON-STERILE ISOLATION GOWN
Applicant	American Seal Co.
Product code	FYC
Device class	Class II
Decision date	May 27, 1997
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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NON-STERILE ISOLATION GOWN

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