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FDA 510(k) Application Details - K213703
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K213703
Device Name
Gown, Surgical
Applicant
Wujiang Tutaike Textiles & Finishing Co., Ltd.
No.1599, South 3rd Ring Road, Shengze, Wujiang
Suzhou 317605 CN
Other 510(k) Applications for this Company
Contact
Zhang Yanwen
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FYA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/24/2021
Decision Date
03/04/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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