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FDA 510(k) Application Details - K123110
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K123110
Device Name
Laparoscope, General & Plastic Surgery
Applicant
SURGICAL INNOVATIONS PLC
CLAYTON WOOD HOUSE,
6 CLAYTON WOOD BANK
LEEDS, WEST YORKSHIRE LS16 6ZQ GB
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Contact
TRACEY FEARNLEY
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
10/03/2012
Decision Date
01/17/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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