510(k) K022979

LAPARETTE, MODEL LAP J L S H N by Instruments Medicaux G.B., Inc. — Product Code KNF

K022979 is an FDA 510(k) premarket notification submitted by Instruments Medicaux G.B., Inc. for the device "LAPARETTE, MODEL LAP J L S H N". The FDA issued a decision of Substantially Equivalent on December 18, 2002. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Instruments Medicaux G.B., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2002
Date Received
September 9, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type