The following data is part of a premarket notification filed by Water Pure, Inc. with the FDA for Hd-100 Hemodialysis Systems And Accessories.
| Device ID | K863720 |
| 510k Number | K863720 |
| Device Name: | HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES |
| Classification | Subsystem, Water Purification |
| Applicant | WATER PURE, INC. 507 BRANDON RD. Louisville, KY 40207 |
| Contact | Wathen, M.d. |
| Correspondent | Wathen, M.d. WATER PURE, INC. 507 BRANDON RD. Louisville, KY 40207 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1986-10-29 |