The following data is part of a premarket notification filed by Precision Therapeutics, Inc. with the FDA for Tapeless Eye Shield.
| Device ID | K872659 |
| 510k Number | K872659 |
| Device Name: | TAPELESS EYE SHIELD |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | PRECISION THERAPEUTICS, INC. 2927 SOUTH INDUSTRIAL RD. Las Vegas, NV 89109 |
| Contact | Leonardi, M.d. |
| Correspondent | Leonardi, M.d. PRECISION THERAPEUTICS, INC. 2927 SOUTH INDUSTRIAL RD. Las Vegas, NV 89109 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-07 |
| Decision Date | 1987-07-27 |