Name: Predicase
Price: 199 USD

K-number	K163191
Device name	ComfortGuard Surgical Gown, i600, Film Reinforced
Applicant	Gri Medical & Electrical Technology Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Feb 27, 2017
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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ComfortGuard Surgical Gown, i600, Film Reinforced

Everything you need for a 510(k) submission. Nothing you don't.