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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K860746
Device Name AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
Applicant
Travenol Laboratories, S.A.
Londonderry Turnpike
Hooksett,  NH  03104
Applicant Contact ROGER A LEROUX
Correspondent
Travenol Laboratories, S.A.
Londonderry Turnpike
Hooksett,  NH  03104
Correspondent Contact ROGER A LEROUX
Regulation Number880.5440
Classification Product Code
FPB  
Date Received02/27/1986
Decision Date 04/07/1986
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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