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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K130577
Device Name AZUR PUSHABLE 18 & 35 SYSTEM
Applicant
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Applicant Contact CYNTHIA VALENZUELA
Correspondent
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Correspondent Contact CYNTHIA VALENZUELA
Regulation Number870.3300
Classification Product Code
KRD  
Date Received03/05/2013
Decision Date 06/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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