The following data is part of a premarket notification filed by Nephros, Inc. with the FDA for Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu Filter.
Device ID | K110285 |
510k Number | K110285 |
Device Name: | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER |
Classification | Subsystem, Water Purification |
Applicant | NEPHROS, INC. 41 GRAND AVE. River Edge, NJ 07661 |
Contact | James Summerton |
Correspondent | James Summerton NEPHROS, INC. 41 GRAND AVE. River Edge, NJ 07661 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-31 |
Decision Date | 2011-07-14 |