The following data is part of a premarket notification filed by Asahi Medical Co., Ltd with the FDA for Am-bio Extended Range Series Dialyzer, Models Wet And Dry.
| Device ID | K013418 |
| 510k Number | K013418 |
| Device Name: | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ASAHI MEDICAL CO., LTD 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 -1632 |
| Contact | David L West |
| Correspondent | David L West ASAHI MEDICAL CO., LTD 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 -1632 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2002-07-09 |
| Summary: | summary |