The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Eye Bubble.
| Device ID | K912367 |
| 510k Number | K912367 |
| Device Name: | EYE BUBBLE |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | AARON MEDICAL INDUSTRIES 1640 CENTRAL AVE. St. Petersburg, FL 33712 |
| Contact | Robert Saron |
| Correspondent | Robert Saron AARON MEDICAL INDUSTRIES 1640 CENTRAL AVE. St. Petersburg, FL 33712 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-29 |
| Decision Date | 1991-10-02 |