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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 K925478
Device Name ELECTROSURGICAL ELECTRODE
Applicant
MEGA DYNE MEDICAL PRODUCTS, INC.
6202 STRATLER ST.
MURRAY,  UT  84107
Applicant Contact DREW D WEAVER
Correspondent
MEGA DYNE MEDICAL PRODUCTS, INC.
6202 STRATLER ST.
MURRAY,  UT  84107
Correspondent Contact DREW D WEAVER
Regulation Number884.4120
Classification Product Code
HGI  
Date Received10/29/1992
Decision Date 06/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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