FDA 510(k) Application Details - K043513

Device Classification Name Catheter, Recording, Electrode, Reprocessed

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510(K) Number K043513
Device Name Catheter, Recording, Electrode, Reprocessed
Applicant STERILMED, INC.
1140O 73RD AVE. NORTH
MINNEAPOLIS, MN 55369 US
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Contact BRUCE R LESTER
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Regulation Number 870.1220

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Classification Product Code NLH
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Date Received 12/20/2004
Decision Date 03/01/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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