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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 K143218
Device Name Penumbra Smart Coil
Applicant
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Applicant Contact Charles DeNault
Correspondent
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Correspondent Contact Charles DeNault
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received11/10/2014
Decision Date 03/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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