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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K902835
Device Name FTS-100 FLUID TRANSFER SYSTEM
Applicant
Richard James, Inc.
P.O. Box 309
Lynnfield,  MA  01940
Applicant Contact WAYNE A RICHARD
Correspondent
Richard James, Inc.
P.O. Box 309
Lynnfield,  MA  01940
Correspondent Contact WAYNE A RICHARD
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/28/1990
Decision Date 08/10/1990
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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