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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 K122316
Device Name AZUR DETACHABLE 35
Original Applicant
MICROVENTION, INC.
1311 valencia ave
tustin,  CA  92780
Original Contact cynthia valenzuela
Regulation Number870.3300
Classification Product Code
KRD  
Date Received08/01/2012
Decision Date 08/29/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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