The following data is part of a premarket notification filed by Eye Pro Medical Products, Inc. with the FDA for Wink-ease Personal Protective Eyewear.
| Device ID | K873662 |
| 510k Number | K873662 |
| Device Name: | WINK-EASE PERSONAL PROTECTIVE EYEWEAR |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | EYE PRO MEDICAL PRODUCTS, INC. C/O BARNES & THORNBURG 11 SOUTH MERIDIAN STREET Indianapolis, IN 46204 |
| Contact | Steven R Lammert |
| Correspondent | Steven R Lammert EYE PRO MEDICAL PRODUCTS, INC. C/O BARNES & THORNBURG 11 SOUTH MERIDIAN STREET Indianapolis, IN 46204 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-10 |
| Decision Date | 1987-10-02 |