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FDA 510(k) Application Details - K113700
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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510(K) Number
K113700
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
SMITHS MEDICAL ASD, INC.
201 WEST QUEEN ST.
SOUTHINGTON, CT 06489 US
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Contact
BRIAN FARIAS
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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
12/16/2011
Decision Date
03/14/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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