The following data is part of a premarket notification filed by Eye Pro Medical Products, Inc. with the FDA for Wink-ease Disposable Protective.
| Device ID | K860043 |
| 510k Number | K860043 |
| Device Name: | WINK-EASE DISPOSABLE PROTECTIVE |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | EYE PRO MEDICAL PRODUCTS, INC. 3526 STELLHORN RD. Fort Wayne, IN 46815 |
| Contact | Jerry Jaquess |
| Correspondent | Jerry Jaquess EYE PRO MEDICAL PRODUCTS, INC. 3526 STELLHORN RD. Fort Wayne, IN 46815 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-02-07 |