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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubing, fluid delivery
510(k) Number K912103
Device Name LIFESHIELD EXTENSION SET
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact FREDERICK GUSTAFSON
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact FREDERICK GUSTAFSON
Regulation Number880.5440
Classification Product Code
FPK  
Date Received05/13/1991
Decision Date 12/13/1991
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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