The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp Tesio Catheter, Models Mbr-6, Mbl-6, Mbs-6.
| Device ID | K981125 |
| 510k Number | K981125 |
| Device Name: | MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jeanne M Cush |
| Correspondent | Jeanne M Cush MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-27 |
| Decision Date | 1999-02-26 |