NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET


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

Applicant Contact michael j dalton
Correspondent
NORFOLK MEDICAL
7350 n. ridgeway
skokie, 
IL 
60076

Correspodent 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

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No