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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K913308
Device Name IVEX-TPN EXTENSION FILTER 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
FPB  
Date Received07/25/1991
Decision Date 01/15/1992
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
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