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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 K900865
Device Name ADD-A-VIAL II BINARY CONNECTOR
Applicant
KENDALL MCGAW LABORATORIES, INC.
P.O. BOX 25080
SANTA ANA,  CA  92799
Applicant Contact RICHARD J MEADER
Correspondent
KENDALL MCGAW LABORATORIES, INC.
P.O. BOX 25080
SANTA ANA,  CA  92799
Correspondent Contact RICHARD J MEADER
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/23/1990
Decision Date 07/11/1990
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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