The following data is part of a premarket notification filed by Medcomp with the FDA for Split Cath Rg.
| Device ID | K130889 |
| 510k Number | K130889 |
| Device Name: | SPLIT CATH RG |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Timothy Holwick |
| Correspondent | Timothy Holwick 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 | 2013-03-29 |
| Decision Date | 2014-04-28 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPLIT CATH RG 85820368 4731973 Live/Registered |
Medical Components, Inc. 2013-01-10 |