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FDA 510(k) Application Details - K111751
Device Classification Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
More FDA Info for this Device
510(K) Number
K111751
Device Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE, NJ 08876-0151 US
Other 510(k) Applications for this Company
Contact
BRIAN A KANERVIKO
Other 510(k) Applications for this Contact
Regulation Number
884.4150
More FDA Info for this Regulation Number
Classification Product Code
HIN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2011
Decision Date
12/02/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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