The following data is part of a premarket notification filed by American Healthcare Corp. with the FDA for Sodium Bicarbonate Powder/bicarbonate Hemodialysis.
| Device ID | K863631 |
| 510k Number | K863631 |
| Device Name: | SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | AMERICAN HEALTHCARE CORP. 825 HILLSIDE CT. Longmont, CO 80501 |
| Contact | Jim Welsch |
| Correspondent | Jim Welsch AMERICAN HEALTHCARE CORP. 825 HILLSIDE CT. Longmont, CO 80501 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-17 |
| Decision Date | 1986-10-16 |