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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 K912771
Device Name ACACIAS PHARM/PUMP
Applicant
Acacia, Inc.
P.O. Box 1799
Ojai,  CA  93023
Applicant Contact JAMES J SULLIVAN
Correspondent
Acacia, Inc.
P.O. Box 1799
Ojai,  CA  93023
Correspondent Contact JAMES J SULLIVAN
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/24/1991
Decision Date 02/14/1992
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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