The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Hemo-cath Silicone Double Lumen Catheter.
| Device ID | K890029 |
| 510k Number | K890029 |
| Device Name: | HEMO-CATH SILICONE DOUBLE LUMEN CATHETER |
| Classification | Catheter, Subclavian |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Nancy L Williams |
| Correspondent | Nancy L Williams MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-04 |
| Decision Date | 1989-04-17 |