The following data is part of a premarket notification filed by Ecolab Inc. with the FDA for Ecolab Pou Water Filter Spray Outlet, Ecolab Pou Water Filter Nozzle Outlet, Ecolab Pou Water Filter Shower Wand.
Device ID | K182164 |
510k Number | K182164 |
Device Name: | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand |
Classification | System, Water Purification, General Medical Use |
Applicant | Ecolab Inc. 1 Ecolab Place St Paul, MN 55102 -2739 |
Contact | Jennifer Willner |
Correspondent | Charles Pouliot Ecolab Inc. 1 Ecolab Place St Paul, MN 55102 -2739 |
Product Code | NHV |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-10 |
Decision Date | 2019-03-29 |