510(k) K200493

Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover by Stryker Corporation — Product Code FXY

K200493 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover". The FDA issued a decision of Substantially Equivalent on March 21, 2020. The device falls under product code FXY (Hood, Surgical), a Class II device regulated under 21 CFR 878.4040. Stryker Corporation has at least 10 other 510(k) clearances on record.