The following data is part of a premarket notification filed by Medcomp with the FDA for Medcomp Sc4.
| Device ID | K022678 |
| 510k Number | K022678 |
| Device Name: | MEDCOMP SC4 |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Florence A Caikoski |
| Correspondent | Florence A Caikoski 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 | 2002-08-12 |
| Decision Date | 2003-02-24 |
| Summary: | summary |