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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 K870187
Device Name NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT
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 Number880.5965
Classification Product Code
LJT  
Date Received01/16/1987
Decision Date 05/07/1987
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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