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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K791496
Device Name LOW PLASTICIZER ADMINISTRATION SETS
Applicant
TRAVENOL LABORATORIES, S.A.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRAVENOL LABORATORIES, S.A.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/03/1979
Decision Date 04/08/1980
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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