The following data is part of a premarket notification filed by A & A Medical Supplies Co. with the FDA for Photo-therapy Eye Protector.
| Device ID | K840894 |
| 510k Number | K840894 |
| Device Name: | PHOTO-THERAPY EYE PROTECTOR |
| Classification | Pad, Neonatal Eye |
| Applicant | A & A MEDICAL SUPPLIES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FOK |
| CFR Regulation Number | 880.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-27 |
| Decision Date | 1984-03-23 |