The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Naturalyte Bicarbonate Dialysate 4400.
| Device ID | K823115 |
| 510k Number | K823115 |
| Device Name: | NATURALYTE BICARBONATE DIALYSATE 4400 |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | ERIKA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-21 |
| Decision Date | 1982-12-03 |