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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K112713
Device Name NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
Applicant
Norfolk Medical Products, Inc.
7350 N. Ridgeway
Skokie,  IL  60076
Applicant Contact MICHAEL DALTON
Correspondent
Norfolk Medical Products, Inc.
7350 N. Ridgeway
Skokie,  IL  60076
Correspondent Contact MICHAEL DALTON
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/19/2011
Decision Date 10/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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