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FDA 510(k) Application Details - K131998
Device Classification Name
More FDA Info for this Device
510(K) Number
K131998
Device Name
ASPIRE RX-LP6 ASPIRATION CATHETER
Applicant
CONTROL MEDICAL TECHNOLOGY, LLC
136 HEBER AVENUE, SUITE 101
PO BOX 681013
PARK CITY, UT 84068 US
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Contact
SHAWN FOJTIK
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Regulation Number
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Classification Product Code
QEZ
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Date Received
06/28/2013
Decision Date
11/26/2013
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
Y
Expedited Review
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