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FDA 510(k) Application Details - K100442
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K100442
Device Name
Laparoscope, General & Plastic Surgery
Applicant
SURGICAL INNOVATIONS GROUP PLC
CLAYTON WOOD HOUSE
6 CLAYTON WOOD BANK
LEEDS WEST YORKSHIRE LS16,6QZ GB
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Contact
MIKE WHITE
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
02/17/2010
Decision Date
09/07/2010
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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