The following data is part of a premarket notification filed by Evoqua Water Technologies, Llc with the FDA for Nosogard Filters.
Device ID | K153784 |
510k Number | K153784 |
Device Name: | NOSOGARD FILTERS |
Classification | System, Water Purification, General Medical Use |
Applicant | Evoqua Water Technologies, LLC 10 Technology Drive Lowell, MA 01851 |
Contact | Robert Dudek |
Correspondent | Robert Dudek Evoqua Water Technologies, LLC 10 Technology Drive Lowell, MA 01851 |
Product Code | NHV |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-12-31 |
Decision Date | 2016-10-21 |
Summary: | summary |