FDA 510(k) Applications for Medical Device Product Code "FXY"
(Hood, Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K140588 STRYKER CORPORATION FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS 06/26/2014
K200493 Stryker Corporation Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover 03/21/2020


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