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 |