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FDA 510(k) Application Details - K954283
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K954283
Device Name
Set, Administration, Intravascular
Applicant
ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3537 US
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Contact
DAVID T GUZEK
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
09/05/1995
Decision Date
05/29/1996
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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