Name: Predicase
Price: 199 USD

K-number	K162442
Device name	ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
Applicant	Gri Medical & Electrical Technology Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Dec 12, 2016
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

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