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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
Recalls CDRH Recalls
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