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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 K896544
Device Name MD2 PERSONAL INFUSION SYSTEM
Applicant
Norfolk Medical Products, Inc.
7307 N. Ridgeway
Skokie,  IL  60076
Applicant Contact MICHAEL J DALTON
Correspondent
Norfolk Medical Products, Inc.
7307 N. Ridgeway
Skokie,  IL  60076
Correspondent Contact MICHAEL J DALTON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/17/1989
Decision Date 05/02/1990
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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