FDA 510(k) Application Details - K011646

Device Classification Name Catheter, Continuous Flush

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510(K) Number K011646
Device Name Catheter, Continuous Flush
Applicant NEURO VASX, INC.
7351 KIRKWOOD LANE, SUITE 112
MAPLE GROVE, MN 55369 US
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Contact JACK SLOVICK
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 05/29/2001
Decision Date 08/27/2001
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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