T4/T5 HYTREL TOGAS

Gown, Surgical

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for T4/t5 Hytrel Togas.

Pre-market Notification Details

Device IDK121664
510k NumberK121664
Device Name:T4/T5 HYTREL TOGAS
ClassificationGown, Surgical
Applicant STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo,  MI  49001
ContactCasey A Metzger
CorrespondentCasey A Metzger
STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo,  MI  49001
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-05
Decision Date2014-03-10

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