The following data is part of a premarket notification filed by Pure Water, Inc. with the FDA for Pure Water Inc's Acidified Storage And Distribution System With Optional Remote Fill.
| Device ID | K993058 |
| 510k Number | K993058 |
| Device Name: | PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL |
| Classification | Tank, Holding, Dialysis |
| Applicant | PURE WATER, INC. 305 WEST MARKET ST. Anderson, SC 29624 |
| Contact | Rhonda S Mccoy |
| Correspondent | Rhonda S Mccoy PURE WATER, INC. 305 WEST MARKET ST. Anderson, SC 29624 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-13 |
| Decision Date | 2000-01-24 |
| Summary: | summary |