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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K941435
Device Name BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD
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 Number878.4400
Classification Product Code
GEI  
Date Received03/24/1994
Decision Date 04/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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