The following data is part of a premarket notification filed by Medcomp (medical Components) with the FDA for Medcomp Gen Iii Power Injectable Port.
| Device ID | K132177 |
| 510k Number | K132177 |
| Device Name: | MEDCOMP GEN III POWER INJECTABLE PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Sarah Shaffer |
| Correspondent | Sarah Shaffer 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 | 2013-07-15 |
| Decision Date | 2013-12-12 |
| Summary: | summary |