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FDA 510(k) Application Details - K211809
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K211809
Device Name
Gown, Surgical
Applicant
Wuhan Dymex Healthcare Co., Ltd.
Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5
Dongfeng Avenue
Wuhan 430000 CN
Other 510(k) Applications for this Company
Contact
Lynn Wu
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
06/11/2021
Decision Date
10/18/2021
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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