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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 K082461
Device Name BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
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 Received08/27/2008
Decision Date 10/02/2008
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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