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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 K180008
Device Name Penumbra System
Applicant
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Applicant Contact Richard Kimura
Correspondent
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Correspondent Contact Michaela Mahl
Regulation Number870.1250
Classification Product Code
NRY  
Date Received01/02/2018
Decision Date 06/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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