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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 K012678
Device Name REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Applicant Contact PATICK FLEISCHHACKER
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Correspondent Contact PATICK FLEISCHHACKER
Regulation Number870.1220
Classification Product Code
NLH  
Date Received08/14/2001
Decision Date 08/14/2002
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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