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

Hood, Surgical

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered With Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover.

Pre-market Notification Details

Device IDK200493
510k NumberK200493
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
ClassificationHood, Surgical
Applicant Stryker Corporation 4100 E. Milham Avenue Kalamazoo,  MI  49001
ContactCorinne Larke-grass
CorrespondentCorinne Larke-grass
Stryker Corporation 4100 E. Milham Avenue Kalamazoo,  MI  49001
Product CodeFXY  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-28
Decision Date2020-03-21

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