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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 K051220
Device Name REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Applicant Contact BRUCE R LESTER
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Correspondent Contact BRUCE R LESTER
Regulation Number870.1220
Classification Product Code
NLH  
Date Received05/12/2005
Decision Date 06/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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