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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 K103305
Device Name PENUMBRA EMBOLIZATION COIL SYSTEM
Applicant
PENUMBRA, INC.
1351 HARBOR BAY PARKWAY
ALAMEDA,  CA  94502
Applicant Contact SETH A SCHULMAN
Correspondent
PENUMBRA, INC.
1351 HARBOR BAY PARKWAY
ALAMEDA,  CA  94502
Correspondent Contact SETH A SCHULMAN
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received11/09/2010
Decision Date 01/26/2011
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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