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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 K895109
Device Name SECONDARY IV SET WITH PROTECTED NEEDLE
Applicant
KENDALL MCGAW LABORATORIES, INC.
P.O. BOX 25080
SANTA ANA,  CA  92799
Applicant Contact RICHARD MEADER
Correspondent
KENDALL MCGAW LABORATORIES, INC.
P.O. BOX 25080
SANTA ANA,  CA  92799
Correspondent Contact RICHARD MEADER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/15/1989
Decision Date 09/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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