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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, neurovascular embolization
510(k) Number K090168
Device Name AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
Applicant
MICROVENTION, INC.
75 COLUMBIA
ALISO VIEJO,  CA  92656 -1408
Applicant Contact FLORIN TRUUVERT
Correspondent
MICROVENTION, INC.
75 COLUMBIA
ALISO VIEJO,  CA  92656 -1408
Correspondent Contact FLORIN TRUUVERT
Regulation Number882.5950
Classification Product Code
HCG  
Date Received01/23/2009
Decision Date 03/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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