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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coagulator-cutter, endoscopic, unipolar (and accessories)
510(k) Number K022979
Device Name LAPARETTE, MODEL LAP J L S H N
Applicant
INSTRUMENTS MEDICAUX G.B., INC.
1184 BLVD. ALEXANDRE
SHERBROOKE, QUEBEC,  CA
Applicant Contact MARTIN PAQUETTE
Correspondent
INSTRUMENTS MEDICAUX G.B., INC.
1184 BLVD. ALEXANDRE
SHERBROOKE, QUEBEC,  CA
Correspondent Contact MARTIN PAQUETTE
Regulation Number884.4160
Classification Product Code
KNF  
Date Received09/09/2002
Decision Date 12/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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