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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, thrombus retriever
510(k) Number K072718
Device Name PENUMBRA SYSTEM
Applicant
PENUMBRA, INC.
2401 MERCED ST., SUITE 200
SAN LEANDRO,  CA  94577
Applicant Contact THERESA BRANDNER-ALLEN
Correspondent
PENUMBRA, INC.
2401 MERCED ST., SUITE 200
SAN LEANDRO,  CA  94577
Correspondent Contact THERESA BRANDNER-ALLEN
Regulation Number870.1250
Classification Product Code
NRY  
Date Received09/25/2007
Decision Date 12/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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