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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocautery, gynecologic (and accessories)
510(k) Number K982739
Device Name GYNEX ELECTRODES
Applicant
GYNEX CORP.
200 GREGORY LANE, SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
GYNEX CORP.
200 GREGORY LANE, SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number884.4120
Classification Product Code
HGI  
Date Received08/06/1998
Decision Date 03/12/1999
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
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