The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp Peritoneal Dialysis Catheters.
| Device ID | K915490 |
| 510k Number | K915490 |
| Device Name: | MEDCOMP PERITONEAL DIALYSIS CATHETERS |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Ann Emele |
| Correspondent | Ann Emele MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-06 |
| Decision Date | 1994-02-02 |