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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
Original Applicant
STERILMED, INC.
11400 73rd ave. north
maple grove,  MN  55369
Original Contact jason skramsted
Regulation Number870.1220
Classification Product Code
NLH  
Date Received04/16/2012
Decision Date 08/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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