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 |