The following data is part of a premarket notification filed by Williams Medical Co. with the FDA for Sodium Bicarbonate, U.s.p..
| Device ID | K891159 |
| 510k Number | K891159 |
| Device Name: | SODIUM BICARBONATE, U.S.P. |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | WILLIAMS MEDICAL CO. 16 CLEWES RD. Millis, MA 02054 |
| Contact | Harding, Jr. |
| Correspondent | Harding, Jr. WILLIAMS MEDICAL CO. 16 CLEWES RD. Millis, MA 02054 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-06 |
| Decision Date | 1989-04-07 |