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FDA 510(k) Application Details - K132020
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K132020
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402 US
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Contact
STEVEN LAWRIE
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
LIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/01/2013
Decision Date
10/25/2013
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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