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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 K103726
Device Name JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
Applicant
INTEGRA LIFESCIENCES CORPORATION
589 DAVIES DRIVE
YORK,  PA  17402
Applicant Contact STEPHANIE SHEESLEY
Correspondent
INTEGRA LIFESCIENCES CORPORATION
589 DAVIES DRIVE
YORK,  PA  17402
Correspondent Contact STEPHANIE SHEESLEY
Regulation Number884.4160
Classification Product Code
KNF  
Date Received12/22/2010
Decision Date 02/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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