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FDA 510(k) Application Details - K082290
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K082290
Device Name
Catheter, Percutaneous
Applicant
PENUMBRA, INC.
1351 HARBOR BAY PKWY.
ALAMEDA, CA 94502 US
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Contact
THERESA BRANDNER-ALLEN
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
08/11/2008
Decision Date
10/31/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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