The following data is part of a premarket notification filed by Eaton Medical Corp. with the FDA for Spirit Shield.
| Device ID | K931718 |
| 510k Number | K931718 |
| Device Name: | SPIRIT SHIELD |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | EATON MEDICAL CORP. 2288 DUNN AVE. Memphis, TN 38114 |
| Contact | Bron Eaton |
| Correspondent | Bron Eaton EATON MEDICAL CORP. 2288 DUNN AVE. Memphis, TN 38114 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-06 |
| Decision Date | 1993-09-20 |