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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, Bipolar (And Accessories)
510(k) Number K990147
Device Name BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771
Applicant
Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy.
Vernon Hills,  IL  60061
Applicant Contact ROBERT L CASARSA
Correspondent
Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact ROBERT L CASARSA
Regulation Number884.4150
Classification Product Code
HIN  
Date Received01/19/1999
Decision Date 04/16/1999
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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