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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 K941214
Device Name LIFESHIELD EXTENSION SET
Applicant
ABBOTT MFG., INC.
ONE ABBOTT PARK
ABBOTT PARK,  IL  60064
Applicant Contact FREDERICK A GUSTAFSON
Correspondent
ABBOTT MFG., INC.
ONE ABBOTT PARK
ABBOTT PARK,  IL  60064
Correspondent Contact FREDERICK A GUSTAFSON
Regulation Number880.5440
Classification Product Code
FPK  
Date Received03/10/1994
Decision Date 10/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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