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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Laparoscopic, Unipolar (And Accessories)
510(k) Number K991424
Device Name INSULSCAN INSULATION TESTING SYSTEM
Applicant
Medicor Corp.
150 Fairway Dr.
Suite 164
Vernon Hills,  IL  60061
Applicant Contact SCOTT B KERRIGAN
Correspondent
Medicor Corp.
150 Fairway Dr.
Suite 164
Vernon Hills,  IL  60061
Correspondent Contact SCOTT B KERRIGAN
Regulation Number884.4160
Classification Product Code
HFG  
Date Received04/23/1999
Decision Date 07/22/1999
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
Predetermined Change
Control Plan Authorized		 No
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