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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 K940191
Device Name ELECTROSURGICAL LOOP ELECTRODE
Applicant
NATIONAL WIRE & STAMPING, INC.
2801 SOUTH VALLEJO ST.
ENGLEWOOD,  CO  80110 -1298
Applicant Contact DAVID W WAGNER
Correspondent
NATIONAL WIRE & STAMPING, INC.
2801 SOUTH VALLEJO ST.
ENGLEWOOD,  CO  80110 -1298
Correspondent Contact DAVID W WAGNER
Regulation Number884.4120
Classification Product Code
HGI  
Date Received01/13/1994
Decision Date 12/30/1994
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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