The following data is part of a premarket notification filed by Pure Water Solutions, Inc. with the FDA for Pure Water-cds (central Dialysis Solution).
| Device ID | K994279 |
| 510k Number | K994279 |
| Device Name: | PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) |
| Classification | Subsystem, Water Purification |
| Applicant | PURE WATER SOLUTIONS, INC. 14550 EAST EASTER AVE., #800 Englewood, CO 80112 -4271 |
| Contact | Dean S Lewis |
| Correspondent | Dean S Lewis PURE WATER SOLUTIONS, INC. 14550 EAST EASTER AVE., #800 Englewood, CO 80112 -4271 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B486W5TDIMB10360FSQR0 | K994279 | 000 |
| B486W5TDICAR0045FFQR0 | K994279 | 000 |
| B486W5TDICAR0054FFQR0 | K994279 | 000 |
| B486W5TDICAR0079FFQR0 | K994279 | 000 |
| B486W5TDICAR0360FSQR0 | K994279 | 000 |
| B486W5TDICAR0500FSQR0 | K994279 | 000 |
| B486W5TDICAR0600FSQR0 | K994279 | 000 |
| B486W5TDICAT0025FFQR0 | K994279 | 000 |
| B486W5TDILIG0025FFQR0 | K994279 | 000 |
| B486W5TDILIG0045FFQR0 | K994279 | 000 |
| B486W5TDILIG0054FFQR0 | K994279 | 000 |
| B486W5TDILIG0079FFQR0 | K994279 | 000 |
| B486W5TDILIG0360FSQR0 | K994279 | 000 |
| B486W5TDILIG0500FSQR0 | K994279 | 000 |
| B486W5TDILIG0600FSQR0 | K994279 | 000 |
| B486W5TDIMB10045FFQR0 | K994279 | 000 |
| B486W5TDICAR0025FFQR0 | K994279 | 000 |