The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Soft-line Ij Double Lumen Catheter 11.5fr X 12cm, Soft-line Ij Double Lumen Catheter 11.5fr X 15cm, Soft-line Lumen Cath.
| Device ID | K983511 |
| 510k Number | K983511 |
| Device Name: | SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH |
| Classification | Catheter, Hemodialysis, Non-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 | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-07 |
| Decision Date | 1999-06-08 |