FDA 510(k) Application Details - K152625

Device Classification Name Catheter, Continuous Flush

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510(K) Number K152625
Device Name Catheter, Continuous Flush
Applicant MicroMedical Solutions, Inc.
790 Willard Street
#209
Quincy, MA 02169 US
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Contact Gregory Mathison
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 09/15/2015
Decision Date 03/09/2016
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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