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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. NORTH
MAPLE GROVE,  MN  55369
Applicant Contact PATRICK FLEISCHHACKER
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
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
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