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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 K012985
Device Name MATRIX DETACHABLE COILS
Applicant
BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT,  CA  94538
Applicant Contact SETH A SCHULMAN
Correspondent
BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT,  CA  94538
Correspondent Contact SETH A SCHULMAN
Regulation Number882.5950
Classification Product Code
HCG  
Date Received09/06/2001
Decision Date 01/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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