The following data is part of a premarket notification filed by Medical Components Inc with the FDA for Dignity Power Injectable Titanium Port.
| Device ID | K120281 |
| 510k Number | K120281 |
| Device Name: | DIGNITY POWER INJECTABLE TITANIUM PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Rosanna Severini |
| Correspondent | Rosanna Severini MEDICAL COMPONENTS INC 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 | 2012-01-31 |
| Decision Date | 2012-09-17 |
| Summary: | summary |