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FDA 510(k) Application Details - K211036
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K211036
Device Name
Gown, Surgical
Applicant
Foshan Nanhai Plus Medical CO LTD
Shatou Jiujiang Town, Nanhai District
Foshan 528200 CN
Other 510(k) Applications for this Company
Contact
Eric Li
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
04/07/2021
Decision Date
05/04/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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