The following data is part of a premarket notification filed by Amuchina Intl., Inc. with the FDA for Amukin-50% For Capd Y-set.
| Device ID | K862928 |
| 510k Number | K862928 |
| Device Name: | AMUKIN-50% FOR CAPD Y-SET |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | AMUCHINA INTL., INC. 12120A HERITAGE PARK CIRCLE Silver Spring, MD 20906 |
| Contact | Bernard J Cooney |
| Correspondent | Bernard J Cooney AMUCHINA INTL., INC. 12120A HERITAGE PARK CIRCLE Silver Spring, MD 20906 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-01 |
| Decision Date | 1987-03-09 |