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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Surgical
510(k) Number K843497
Device Name SURGICAL KNIVES & PROBES
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 Number878.4800
Classification Product Code
EMF  
Date Received09/06/1984
Decision Date 10/31/1984
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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