Name: Predicase
Price: 199 USD

K-number	K200493
Device name	Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
Applicant	Stryker Corporation
Product code	FXY
Device class	Class II
Decision date	Mar 21, 2020
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover

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