The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for Hemosorba Ch-500, Ch-350 And Ch-180.
| Device ID | K885017 |
| 510k Number | K885017 |
| Device Name: | HEMOSORBA CH-500, CH-350 AND CH-180 |
| Classification | Apparatus, Hemoperfusion, Sorbent |
| Applicant | ASAHI MEDICAL CO., LTD. INTL. SQUARE 1825 EYE ST., N.W., SUITE 400 Washington, DC 20006 |
| Contact | Anderson |
| Correspondent | Anderson ASAHI MEDICAL CO., LTD. INTL. SQUARE 1825 EYE ST., N.W., SUITE 400 Washington, DC 20006 |
| Product Code | FLD |
| CFR Regulation Number | 876.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-05 |
| Decision Date | 1989-03-17 |