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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K865060
Device Name I.V. SET WITH DUAL-CHANNEL CASSETTE
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact F. A GUSTAFSON
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact F. A GUSTAFSON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/24/1986
Decision Date 02/06/1987
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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