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FDA 510(k) Application Details - K152934
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K152934
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
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
870.1250
More FDA Info for this Regulation Number
Classification Product Code
LIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/05/2015
Decision Date
04/25/2016
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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