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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 north ridgeway
skokie,  IL  60076
Contact michael dalton
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/28/2011
Decision Date 10/27/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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