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

Port & Catheter, Implanted, Subcutaneous, Intravascular

MEDCOMP (MEDICAL COMPONENTS)

The following data is part of a premarket notification filed by Medcomp (medical Components) with the FDA for Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile Port- Attachable; Dignity Low Profil.

Pre-market Notification Details

Device IDK110424
510k NumberK110424
Device Name:DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville,  PA  19438
ContactJean Callow
CorrespondentJean Callow
MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville,  PA  19438
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-14
Decision Date2011-11-30
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.