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.
| Device ID | K110424 |
| 510k Number | K110424 |
| Device Name: | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville, PA 19438 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-11-30 |
| Summary: | summary |