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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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