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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 K860492
Device Name NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE
Applicant
Nordisk Infuser System
1140 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact MICHAEL F COLE
Correspondent
Nordisk Infuser System
1140 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact MICHAEL F COLE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/03/1986
Decision Date 02/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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