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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 K852060
Device Name INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
Applicant
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Applicant Contact ANN H MORRISSEY
Correspondent
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Correspondent Contact ANN H MORRISSEY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/09/1985
Decision Date 06/07/1985
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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