The following data is part of a premarket notification filed by Phs Medical Gmbh with the FDA for C-port - Hp Power Injectable Port.
| Device ID | K091099 |
| 510k Number | K091099 |
| Device Name: | C-PORT - HP POWER INJECTABLE PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | PHS MEDICAL GMBH 2360 JOHNSON RD. Southlake, TX 76092 |
| Contact | Donald F Hults |
| Correspondent | Donald F Hults PHS MEDICAL GMBH 2360 JOHNSON RD. Southlake, TX 76092 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-16 |
| Decision Date | 2009-05-22 |
| Summary: | summary |