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FDA 510(k) Application Details - K955410
Device Classification Name
Set, Administration, Intravascular
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510(K) Number
K955410
Device Name
Set, Administration, Intravascular
Applicant
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-3537 US
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Contact
DAVID 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
11/27/1995
Decision Date
05/06/1996
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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