The following data is part of a premarket notification filed by Nipro Renal Solutions Usa, Corp. with the FDA for Nipro Dry Complete Dry Acid Concentrate For Hemodialysis.
| Device ID | K193155 |
| 510k Number | K193155 |
| Device Name: | Nipro Dry Complete Dry Acid Concentrate For Hemodialysis |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | Nipro Renal Solutions USA, Corp. 509 Fishing Creek Road Lewisberry, PA 17339 |
| Contact | Vincent Degrandchamp |
| Correspondent | David M Marcus McNees Wallace & Nurick LLC 21 East State Street, Suite 1700 Columbus, OH 43215 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-14 |
| Decision Date | 2020-11-25 |