The following data is part of a premarket notification filed by Amuchina Intl., Inc. with the FDA for Amukin D.
| Device ID | K992016 |
| 510k Number | K992016 |
| Device Name: | AMUKIN D |
| Classification | Dialyzer Reprocessing System |
| Applicant | AMUCHINA INTL., INC. 8-8 METROPOLITAN CT. Gaithersburg, MD 20878 |
| Contact | Ludovico Giavotto |
| Correspondent | Ludovico Giavotto AMUCHINA INTL., INC. 8-8 METROPOLITAN CT. Gaithersburg, MD 20878 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-15 |
| Decision Date | 2000-01-10 |