The following data is part of a premarket notification filed by Mar Cor Purification, Inc. with the FDA for Millenium Hx.
| Device ID | K192398 |
| 510k Number | K192398 |
| Device Name: | Millenium HX |
| Classification | Subsystem, Water Purification |
| Applicant | Mar Cor Purification, Inc. 14550 28th Avenue North Minneapolis, MN 55447 |
| Contact | Mike Halliday |
| Correspondent | Mark Arnold Cantel 9800 59th Ave. N Plymouth, MN 55442 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2019-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817492022508 | K192398 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MILLENIUM HX 85750070 4346560 Live/Registered |
Mar Cor Purification Inc. 2012-10-10 |