The following data is part of a premarket notification filed by Pure Water, Inc. with the FDA for Pure Water, Inc.'s Water Purification Systems.
Device ID | K992786 |
510k Number | K992786 |
Device Name: | PURE WATER, INC.'S WATER PURIFICATION SYSTEMS |
Classification | Subsystem, Water Purification |
Applicant | PURE WATER, INC. 305 WEST MARKET ST. Anderson, SC 29624 |
Contact | Cynthia P Walters |
Correspondent | Cynthia P Walters PURE WATER, INC. 305 WEST MARKET ST. Anderson, SC 29624 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-19 |
Decision Date | 2000-01-24 |
Summary: | summary |