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FDA 510(k) Application Details - K152625
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1210
More FDA Info for this Regulation Number
Classification Product Code
KRA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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