The following data is part of a premarket notification filed by Midwest R.f. Llc. with the FDA for Mep-90 Hair Growth Stimulation System.
| Device ID | K091496 |
| 510k Number | K091496 |
| Device Name: | MEP-90 HAIR GROWTH STIMULATION SYSTEM |
| Classification | Laser, Comb, Hair |
| Applicant | MIDWEST R.F. LLC. 1050 WALNUT RIDGE DRIVE Hartland, WI 53029 |
| Contact | Helmut Keidl |
| Correspondent | Helmut Keidl MIDWEST R.F. LLC. 1050 WALNUT RIDGE DRIVE Hartland, WI 53029 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-20 |
| Decision Date | 2010-02-23 |
| Summary: | summary |