The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Health Care Eye Protection.
| Device ID | K875107 |
| 510k Number | K875107 |
| Device Name: | HEALTH CARE EYE PROTECTION |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | SURGIKOS, INC. P.O. BOX 130 Arlington, TX 76010 |
| Contact | Walter J Mcquade |
| Correspondent | Walter J Mcquade SURGIKOS, INC. P.O. BOX 130 Arlington, TX 76010 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-14 |
| Decision Date | 1988-03-21 |