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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological, Reprocessed
510(k) Number K012685
Device Name REPROCESSED ENDOSCOPIC ELECTRODES
Applicant
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Applicant Contact PATRICK FLEISCHHACKER
Correspondent
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Correspondent Contact PATRICK FLEISCHHACKER
Regulation Number876.4300
Classification Product Code
NLW  
Date Received08/14/2001
Decision Date 02/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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