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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 K874467
Device Name SET, ADMINISTRATION INTRAVASCULAR
Applicant
KENDALL MCGAW LABORATORIES, INC.
P.O. BOX 25080
SANTA ANA,  CA  92799
Applicant Contact JOYCE WILLIAMS
Correspondent
KENDALL MCGAW LABORATORIES, INC.
P.O. BOX 25080
SANTA ANA,  CA  92799
Correspondent Contact JOYCE WILLIAMS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/02/1987
Decision Date 01/06/1988
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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