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FDA 510(k) Application Details - K221977
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K221977
Device Name
Gown, Surgical
Applicant
Xiantao Topmed Nonwoven Protective Products Co., Ltd.
North of the National Road 318,
Tongjiazui Village,Huchang Town
Xiantao 433000 CN
Other 510(k) Applications for this Company
Contact
Vivian Zhu
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
07/05/2022
Decision Date
10/20/2022
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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