The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp Ash Split.
| Device ID | K011576 |
| 510k Number | K011576 |
| Device Name: | MEDCOMP ASH SPLIT |
| Classification | Kit, Repair, Catheter, Hemodialysis |
| 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 | NFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-22 |
| Decision Date | 2001-06-21 |
| Summary: | summary |