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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Pneumatic Powered
510(k) Number K843498
Device Name BIPOLAR SUCTION ELECTRODE
Applicant
Eder Instrument Co, Inc.
735 N. Water St.
Suite 1102
Milwaukee, Wi 53202,  53202
Applicant Contact DANIEL D FETTERLEY
Correspondent
Eder Instrument Co, Inc.
735 N. Water St.
Suite 1102
Milwaukee, Wi 53202,  53202
Correspondent Contact DANIEL D FETTERLEY
Regulation Number878.4820
Classification Product Code
GET  
Date Received09/06/1984
Decision Date 12/14/1984
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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