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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Recording, Electrode, Reprocessed
510(k) Number K043513
Device Name STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
Applicant
Sterilmed, Inc.
1140o 73rd Ave. N.
Minneapolis,  MN  55369
Applicant Contact BRUCE R LESTER
Correspondent
Sterilmed, Inc.
1140o 73rd Ave. N.
Minneapolis,  MN  55369
Correspondent Contact BRUCE R LESTER
Regulation Number870.1220
Classification Product Code
NLH  
Date Received12/20/2004
Decision Date 03/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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