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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 K850757
Device Name TANDEM SETS I.V.
Applicant
Acacia, Inc.
P.O. Box 1240
Loma Linda,  CA  92354
Applicant Contact JAMES J SULLIVAN
Correspondent
Acacia, Inc.
P.O. Box 1240
Loma Linda,  CA  92354
Correspondent Contact JAMES J SULLIVAN
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/25/1985
Decision Date 04/04/1985
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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