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FDA 510(k) Application Details - K141593
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K141593
Device Name
Laparoscope, General & Plastic Surgery
Applicant
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
R15-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROADS, NANSHAN
DISTRICT
SHENZHEN, GUANGDONG 518054 CN
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Contact
LONG YANG
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/13/2014
Decision Date
11/13/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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