The following data is part of a premarket notification filed by Mar Cor Purification, Inc. with the FDA for Millenium Hx Portable Reverse Osmosis Water Purification System.
| Device ID | K110578 |
| 510k Number | K110578 |
| Device Name: | MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM |
| Classification | Subsystem, Water Purification |
| Applicant | MAR COR PURIFICATION, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55447 |
| Contact | Brent Geiger |
| Correspondent | Brent Geiger MAR COR PURIFICATION, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55447 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-01 |
| Decision Date | 2011-05-20 |
| Summary: | summary |