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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K934119
Device Name ENERGIZED DRUG CONTAINER SYSTEM
Original Applicant
ABBOTT LABORATORIES
d-389, ap-30
200 abbott park road
abbott park,  IL  60064 3537
Original Contact frederick a gustafson
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/25/1993
Decision Date 06/09/1994
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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