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FDA 510(k) Application Details - K123462
Device Classification Name
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510(K) Number
K123462
Device Name
OCELOT CATHETER
Applicant
AVINGER, INC.
400 CHESAPEAKE DRIVE
REDWOOD CITY, CA 94063 US
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Contact
Albert Boniske
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Regulation Number
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Classification Product Code
PDU
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Date Received
11/09/2012
Decision Date
12/07/2012
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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