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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 K954283
Device Name ENERGIZED CONTAINER SYSTEM (MODIFICATION)
Applicant
ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3537
Applicant Contact DAVID T GUZEK
Correspondent
ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact DAVID T GUZEK
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/05/1995
Decision Date 05/29/1996
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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