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FDA 510(k) Application Details - K081690
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K081690
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402 US
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Contact
NATHAN SIMON
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
FOZ
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More FDA Info for this Product Code
Date Received
06/17/2008
Decision Date
07/14/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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