FDA 510(k) Application Details - K150357

Device Classification Name Catheter, Recording, Electrode, Reprocessed

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510(K) Number K150357
Device Name Catheter, Recording, Electrode, Reprocessed
Applicant STERILMED, INC.
5010 Cheshire Pkwy Ste 2
Plymouth, MN 55446 US
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Contact Nicole Boser
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Regulation Number 870.1220

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Classification Product Code NLH
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Date Received 02/12/2015
Decision Date 08/27/2015
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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