510(k) Premarket Notification

• Device Classification Name: port & catheter, implanted, subcutaneous, intravascular
• 510(K) Number: K111101
• Device Name: NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
• Applicant: NORFOLK MEDICAL; 7350 n. ridgeway; skokie, IL 60076
• Contact: michael j dalton
• Regulation Number: 880.5965
• Classification Product Code: LJT
• Date Received: 04/20/2011
• Decision Date: 08/25/2011
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General Hospital
• Review Advisory Committee: General Hospital
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No