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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 K854964
Device Name CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.
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 Received12/11/1985
Decision Date 03/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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