The following data is part of a premarket notification filed by Teknar, Inc. with the FDA for Ophthasonic A/p Iii.
| Device ID | K903666 |
| 510k Number | K903666 |
| Device Name: | OPHTHASONIC A/P III |
| Classification | Unit, Electrolysis, Battery-powered, Ophthalmic |
| Applicant | TEKNAR, INC. 267 WOLFNER DR. Fenton, MO 63026 -2801 |
| Contact | Chuck Kuhlmann |
| Correspondent | Chuck Kuhlmann TEKNAR, INC. 267 WOLFNER DR. Fenton, MO 63026 -2801 |
| Product Code | HPY |
| CFR Regulation Number | 886.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-14 |
| Decision Date | 1990-11-19 |