The following data is part of a premarket notification filed by Sellstrom Mfg. Co. with the FDA for Goggle Safeguard.
| Device ID | K931254 |
| 510k Number | K931254 |
| Device Name: | GOGGLE SAFEGUARD |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | SELLSTROM MFG. CO. SELLSTROM INDUSTRIAL PARK ONE SELLSTROM DR. Palatine, IL 60067 |
| Contact | Lori Butler |
| Correspondent | Lori Butler SELLSTROM MFG. CO. SELLSTROM INDUSTRIAL PARK ONE SELLSTROM DR. Palatine, IL 60067 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-12 |
| Decision Date | 1993-11-12 |