DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL


Device Classification Name

port & catheter, implanted, subcutaneous, intravascular

510(k) Number K110424
Device Name DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
Applicant
MEDCOMP (MEDICAL COMPONENTS)
1499 delp drive
harleysville, 
PA 
19438

Applicant Contact jean callow
Correspondent
MEDCOMP (MEDICAL COMPONENTS)
1499 delp drive
harleysville, 
PA 
19438

Correspodent Contact jean callow
Regulation Number 880.5965
Classification Product Code
LJT  
Date Received 02/14/2011
Decision Date 11/30/2011
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