The following data is part of a premarket notification filed by Nelson Environmental Technologies, Inc. with the FDA for Nelson Water Systems For Hemodialysis.
| Device ID | K993877 |
| 510k Number | K993877 |
| Device Name: | NELSON WATER SYSTEMS FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | NELSON ENVIRONMENTAL TECHNOLOGIES, INC. 301-E N. MCCOLL RD. Mcallen, TX 78501 |
| Contact | Burke A West |
| Correspondent | Burke A West NELSON ENVIRONMENTAL TECHNOLOGIES, INC. 301-E N. MCCOLL RD. Mcallen, TX 78501 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-15 |
| Decision Date | 2000-05-25 |
| Summary: | summary |