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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 K905116
Device Name PHARM-ASSIST
Applicant
Excel Medical, Inc.
P.O. Drawer M
Loma Linda,  CA  92354
Applicant Contact MARGARET LUMIA
Correspondent
Excel Medical, Inc.
P.O. Drawer M
Loma Linda,  CA  92354
Correspondent Contact MARGARET LUMIA
Regulation Number880.5440
Classification Product Code
LHI  
Date Received11/13/1990
Decision Date 04/25/1991
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
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