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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 K090752
Device Name PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
Applicant
PENUMBRA, INC.
1351 HARBOR BAY PKWY.
ALAMEDA,  CA  94502
Applicant Contact LOUISE MUSANTE
Correspondent
PENUMBRA, INC.
1351 HARBOR BAY PKWY.
ALAMEDA,  CA  94502
Correspondent Contact LOUISE MUSANTE
Regulation Number870.1250
Classification Product Code
NRY  
Date Received03/20/2009
Decision Date 09/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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