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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 K930132
Device Name LEEP AND LLETZ ELECTRODES
Applicant
Nordex Medical Corp.
3417 Roger B. Chaffee Blvd.,
Suite 309
Grand Rapids,  MI  49548
Applicant Contact JAY T BAATZ
Correspondent
Nordex Medical Corp.
3417 Roger B. Chaffee Blvd.,
Suite 309
Grand Rapids,  MI  49548
Correspondent Contact JAY T BAATZ
Regulation Number884.4120
Classification Product Code
HGI  
Date Received01/12/1993
Decision Date 05/04/1994
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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