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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 K120630
Device Name AZUR DETACHABLE 18
Original Applicant
MICRO VENTION, INC.
1311 valencia avenue
tustin,  CA  92780
Original Contact cynthia valenzuela
Regulation Number870.3300
Classification Product Code
KRD  
Date Received03/01/2012
Decision Date 03/28/2012
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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