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FDA 510(k) Application Details - K111986
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K111986
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
SURGICAL INNOVATIONS PLC
CLAYTON WOOD HOUSE,
6 CLAYTON WOOD BANK
LEEDS, WEST YORKSHIRE LS16 6ZQ GB
Other 510(k) Applications for this Company
Contact
PAUL BIRTLES
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/13/2011
Decision Date
01/26/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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