The following data is part of a premarket notification filed by Ameco Medical Industries with the FDA for Amecath And Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits.
| Device ID | K110793 |
| 510k Number | K110793 |
| Device Name: | AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | AMECO MEDICAL INDUSTRIES 79 BROOKLINE ROAD Mason, NH 03048 |
| Contact | Ray Kelly |
| Correspondent | Ray Kelly AMECO MEDICAL INDUSTRIES 79 BROOKLINE ROAD Mason, NH 03048 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-22 |
| Decision Date | 2011-12-16 |