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FDA 510(k) Application Details - K171823
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
More FDA Info for this Device
510(K) Number
K171823
Device Name
Indicator, Physical/Chemical Sterilization Process
Applicant
U&U Medical Technology Co., Ltd
Dongzhou Village
Hengshanqiao
Changzhou 213119 CN
Other 510(k) Applications for this Company
Contact
Xuebo Wang
Other 510(k) Applications for this Contact
Regulation Number
880.2800
More FDA Info for this Regulation Number
Classification Product Code
JOJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/19/2017
Decision Date
02/22/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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