The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Twin Silicone Catheter.
| Device ID | K923691 |
| 510k Number | K923691 |
| Device Name: | TWIN SILICONE CATHETER |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Michelle Demers |
| Correspondent | Michelle Demers MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-23 |
| Decision Date | 1995-09-25 |