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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K941207
Device Name MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES
Applicant
NEW EDER CORP.
1451-E LANDMEIER RD.
ELK GROOVE VILLAGE,  IL  60007
Applicant Contact JAIRO E CANAVERAL
Correspondent
NEW EDER CORP.
1451-E LANDMEIER RD.
ELK GROOVE VILLAGE,  IL  60007
Correspondent Contact JAIRO E CANAVERAL
Regulation Number884.4160
Classification Product Code
KNF  
Date Received03/14/1994
Decision Date 01/24/1995
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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