The following data is part of a premarket notification filed by P.j. Products, Inc. with the FDA for Fox Eye Aluminum Shield, Ophthalmic.
| Device ID | K940095 |
| 510k Number | K940095 |
| Device Name: | FOX EYE ALUMINUM SHIELD, OPHTHALMIC |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | P.J. PRODUCTS, INC. 8535 WEST BELLFORT Houston, TX 77071 |
| Contact | Joel H Goffman, M.d. |
| Correspondent | Joel H Goffman, M.d. P.J. PRODUCTS, INC. 8535 WEST BELLFORT Houston, TX 77071 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-07 |
| Decision Date | 1994-03-01 |