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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K853830
Device Name SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST
Applicant
TRAVENOL LABORATORIES, S.A.
DEERFIELD,  IL  60015
Applicant Contact PATRICIA BARSANTI
Correspondent
TRAVENOL LABORATORIES, S.A.
DEERFIELD,  IL  60015
Correspondent Contact PATRICIA BARSANTI
Regulation Number880.5440
Classification Product Code
LHI  
Date Received09/13/1985
Decision Date 11/06/1985
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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