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FDA 510(k) Application Details - K072718
Device Classification Name
Catheter, Thrombus Retriever
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510(K) Number
K072718
Device Name
Catheter, Thrombus Retriever
Applicant
PENUMBRA, INC.
2401 MERCED ST., SUITE 200
SAN LEANDRO, CA 94577 US
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Contact
THERESA BRANDNER-ALLEN
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Regulation Number
870.1250
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Classification Product Code
NRY
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More FDA Info for this Product Code
Date Received
09/25/2007
Decision Date
12/28/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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