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FDA 510(k) Application Details - K220092
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K220092
Device Name
Gown, Surgical
Applicant
HeNan YADU Industrial Co., Ltd.
No. 234, West Jianpu Road
Changyuan 453400 CN
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Contact
Charles Shen
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
01/12/2022
Decision Date
10/07/2022
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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