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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 K905646
Device Name OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY
Applicant
Norfolk Medical
7307 N. Ridgeway
Skokie,  IL  60076
Applicant Contact MICHAEL J DALTON
Correspondent
Norfolk Medical
7307 N. Ridgeway
Skokie,  IL  60076
Correspondent Contact MICHAEL J DALTON
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/17/1990
Decision Date 03/27/1991
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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