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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 K935947
Device Name HI-TOPS ELECTRODES 14-8000
Applicant
W. J. Medical Instruments, Inc.
3537 Old Conejo Rd.
Suite 109
Newbury Park,  CA  91320
Applicant Contact WILLIAM J ZINNANTI
Correspondent
W. J. Medical Instruments, Inc.
3537 Old Conejo Rd.
Suite 109
Newbury Park,  CA  91320
Correspondent Contact WILLIAM J ZINNANTI
Regulation Number884.4160
Classification Product Code
KNF  
Subsequent Product Code
GEI  
Date Received12/13/1993
Decision Date 02/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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