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FDA 510(k) Application Details - K963972
Device Classification Name
Catheter, Umbilical Artery
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510(K) Number
K963972
Device Name
Catheter, Umbilical Artery
Applicant
KLEIN-BAKER MEDICAL, INC.
12001 NETWORK, SUITE 110
SAN ANTONIO, TX 78249 US
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Contact
CLYDE N BAKER
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Regulation Number
880.5200
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Classification Product Code
FOS
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More FDA Info for this Product Code
Date Received
10/03/1996
Decision Date
12/24/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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