The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp Duo-flow Ii Catheter With Lubricious Heparin.
| Device ID | K991320 |
| 510k Number | K991320 |
| Device Name: | MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN |
| 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 | 1999-04-19 |
| Decision Date | 1999-11-10 |
| Summary: | summary |