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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 K040694
Device Name MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
Applicant
MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE,  CA  92618
Applicant Contact FLORIN TRUUVERT
Correspondent
MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE,  CA  92618
Correspondent Contact FLORIN TRUUVERT
Regulation Number882.5950
Classification Product Code
HCG  
Date Received03/17/2004
Decision Date 03/25/2004
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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