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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 K843772
Device Name CADD-1 5100 AMBULATORY INFUSION PUMP
Applicant
DELTEC SYSTEMS, INC.
3800 NORTH DUNLAP AVENUE
ST. PAUL,  MN  55112 -
Applicant Contact THOMAS A DOUGHERTY
Correspondent
DELTEC SYSTEMS, INC.
3800 NORTH DUNLAP AVENUE
ST. PAUL,  MN  55112 -
Correspondent Contact THOMAS A DOUGHERTY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/25/1984
Decision Date 12/06/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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