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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, biliary, reprocessed
510(k) Number K012556
Device Name REPROCESSED GUIDEWIRES
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 Number876.5010
Classification Product Code
NML  
Date Received08/08/2001
Decision Date 04/29/2002
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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