The following data is part of a premarket notification filed by Surgeon Surgical Instrumentation, Inc. with the FDA for Surgin Eye Shield.
| Device ID | K881232 |
| 510k Number | K881232 |
| Device Name: | SURGIN EYE SHIELD |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
| Contact | Stephen M Priolo |
| Correspondent | Stephen M Priolo SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-04-13 |