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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 K853584
Device Name CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP
Applicant
Deltec Systems, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact JAMES E LESLIE
Correspondent
Deltec Systems, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact JAMES E LESLIE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/26/1985
Decision Date 11/12/1985
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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