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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 K121158
Device Name REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Applicant Contact JASON SKRAMSTED
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Correspondent Contact JASON SKRAMSTED
Regulation Number870.1220
Classification Product Code
NLH  
Date Received04/16/2012
Decision Date 08/06/2012
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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