The following data is part of a premarket notification filed by Precision Therapeutics, Inc. with the FDA for Lidsplint.
| Device ID | K864810 |
| 510k Number | K864810 |
| Device Name: | LIDSPLINT |
| Classification | Pad, Eye |
| Applicant | PRECISION THERAPEUTICS, INC. 2320 PLAZA DEL GRANDE Las Vegas, NV 89102 |
| Contact | Leonardi, M.d. |
| Correspondent | Leonardi, M.d. PRECISION THERAPEUTICS, INC. 2320 PLAZA DEL GRANDE Las Vegas, NV 89102 |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-01-20 |