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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K083125
Device Name NEURON SELECT CATHETER SIZE 070
Applicant
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Applicant Contact THERESA BRANDNER-ALLEN
Correspondent
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Correspondent Contact THERESA BRANDNER-ALLEN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/22/2008
Decision Date 11/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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