The following data is part of a premarket notification filed by Medcomp ( Medical Components) with the FDA for Dignity Dual Port.
| Device ID | K153238 |
| 510k Number | K153238 |
| Device Name: | Dignity Dual Port |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | Medcomp ( Medical Components) 1499 Delp Drive Harleysville, PA 19438 |
| Contact | Beth Ann Giammaruti |
| Correspondent | Courtney Nix 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 | 2015-11-09 |
| Decision Date | 2016-03-15 |
| Summary: | summary |