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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
Recalls CDRH Recalls
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