The following data is part of a premarket notification filed by Water Pure, Inc. with the FDA for Hd-400-a/b/c Hemodialysis Systems & Accessories.
| Device ID | K873487 |
| 510k Number | K873487 |
| Device Name: | HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES |
| Classification | Subsystem, Water Purification |
| Applicant | WATER PURE, INC. 11003 BLUEGRASS PKWY. SUITE 600, BLDG. A Louisville, KY 40299 |
| Contact | Ronald L Wathen |
| Correspondent | Ronald L Wathen WATER PURE, INC. 11003 BLUEGRASS PKWY. SUITE 600, BLDG. A Louisville, KY 40299 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-31 |
| Decision Date | 1987-10-23 |