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FDA 510(k) Application Details - K970434
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
More FDA Info for this Device
510(K) Number
K970434
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
KLEIN-BAKER MEDICAL, INC.
12001 NETWORK, SUITE 110
SAN ANTONIO, TX 78249 US
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Contact
CLYDE N BAKER
Other 510(k) Applications for this Contact
Regulation Number
880.5970
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Classification Product Code
LJS
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More FDA Info for this Product Code
Date Received
02/05/1997
Decision Date
04/01/1997
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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