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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 K860272
Device Name SOLUTION ADMINISTRATION SETS
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact BRIAN STEMBAL
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact BRIAN STEMBAL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/27/1986
Decision Date 03/18/1986
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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