The following data is part of a premarket notification filed by Morax with the FDA for Hydragel-mini Lipo Kit-pn 4093, Hydragel Lipo Kit-pn 4007, Hydragel Lipo Maxi Kit-pn 4207.
| Device ID | K974854 |
| 510k Number | K974854 |
| Device Name: | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik MORAX 13805 WATERLOO RD. Chelsea, MI 48118 |
| Product Code | JHO |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-10-07 |
| Summary: | summary |