The following data is part of a premarket notification filed by Lady Comp Usa with the FDA for Lady Comp Usa.
| Device ID | K050094 |
| 510k Number | K050094 |
| Device Name: | LADY COMP USA |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | LADY COMP USA 410 EAST TERRACE HEIGHTS Jeffersonville, IN 47130 |
| Contact | Michael Cartain |
| Correspondent | Michael Cartain LADY COMP USA 410 EAST TERRACE HEIGHTS Jeffersonville, IN 47130 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-14 |
| Decision Date | 2006-04-20 |
| Summary: | summary |