The following data is part of a premarket notification filed by Medcomp with the FDA for 15f X 55cm Excell Split -tip Catheter, Models 10300606, 10300706.
| Device ID | K040992 |
| 510k Number | K040992 |
| Device Name: | 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-16 |
| Decision Date | 2004-07-29 |
| Summary: | summary |