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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
Applicant
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Applicant Contact FREDERICK A GUSTAFSON
Correspondent
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact FREDERICK A GUSTAFSON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/25/1993
Decision Date 06/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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