The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for Asahi Am-r Series Dialyzers.
| Device ID | K970650 |
| 510k Number | K970650 |
| Device Name: | ASAHI AM-R SERIES DIALYZERS |
| Classification | Hemodialyzer, Re-use, Low Flux |
| Applicant | ASAHI MEDICAL CO., LTD. 15825 SHADY GROVE ROAD, SUITE 90 Rockville, MD 20850 |
| Contact | David L West |
| Correspondent | David L West ASAHI MEDICAL CO., LTD. 15825 SHADY GROVE ROAD, SUITE 90 Rockville, MD 20850 |
| Product Code | MSE |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1997-09-30 |
| Summary: | summary |