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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 K850061
Device Name MICRO VOLUME DOUBLE LINE EXTENSION SET
Applicant
Travenol Laboratories, S.A.
Londonderry Tpke.
Hooksett,  NH  03104
Applicant Contact ROGER A LEROUX
Correspondent
Travenol Laboratories, S.A.
Londonderry Tpke.
Hooksett,  NH  03104
Correspondent Contact ROGER A LEROUX
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/08/1985
Decision Date 03/27/1985
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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