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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 K843773
Device Name CADD-PAC 5200 AMBULATORY INFUSION PUMP
Applicant
DELTEC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Applicant Contact THOMAS A DOUGHERTY
Correspondent
DELTEC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
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
Predetermined Change
Control Plan Authorized
No
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