The following data is part of a premarket notification filed by Franklin Medical Usa, Inc. with the FDA for Hayes Vaginal Shield.
| Device ID | K862478 |
| 510k Number | K862478 |
| Device Name: | HAYES VAGINAL SHIELD |
| Classification | Speculum, Vaginal, Metal |
| Applicant | FRANKLIN MEDICAL USA, INC. 26206 W. 12 MILE RD. SUITE 200 Southfield, MI 48034 |
| Contact | Hayes, M.d. |
| Correspondent | Hayes, M.d. FRANKLIN MEDICAL USA, INC. 26206 W. 12 MILE RD. SUITE 200 Southfield, MI 48034 |
| Product Code | HDF |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-30 |
| Decision Date | 1986-11-24 |