The following data is part of a premarket notification filed by Medcomp with the FDA for Power Injectable Implantable Infusion Port With Silicone Lumen (attachable And Pre-attached).
| Device ID | K070003 |
| 510k Number | K070003 |
| Device Name: | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDCOMP 1499 DELP DR. 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 | 2007-01-03 |
| Decision Date | 2007-05-15 |
| Summary: | summary |