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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 K896990
Device Name PHARMULATOR
Applicant
Acacia, Inc.
P.O. Box 1240
Loma Linda,  CA  92354
Applicant Contact MARGARET LUMIA,PHARM
Correspondent
Acacia, Inc.
P.O. Box 1240
Loma Linda,  CA  92354
Correspondent Contact MARGARET LUMIA,PHARM
Regulation Number880.5440
Classification Product Code
LHI  
Date Received12/13/1989
Decision Date 03/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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