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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 S. Vallejo St.
Englewood,  CO  80110
Applicant Contact DAVID W WAGNER
Correspondent
National Wire & Stamping, Inc.
2801 S. Vallejo St.
Englewood,  CO  80110
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
Predetermined Change
Control Plan Authorized		 No
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