The following data is part of a premarket notification filed by Procare C/o Wiley, Rein & Fielding with the FDA for Gender Choice Information Kit, Female And Male.
| Device ID | K870999 |
| 510k Number | K870999 |
| Device Name: | GENDER CHOICE INFORMATION KIT, FEMALE AND MALE |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | PROCARE C/O WILEY, REIN & FIELDING 1776 K STREET, N.W. Washington, DC 20006 |
| Contact | Andrew S Krulwich |
| Correspondent | Andrew S Krulwich PROCARE C/O WILEY, REIN & FIELDING 1776 K STREET, N.W. Washington, DC 20006 |
| 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 | 1987-03-11 |
| Decision Date | 1987-07-14 |