The following data is part of a premarket notification filed by Optic Tech Corp. with the FDA for Frame Spectacle.
| Device ID | K943753 |
| 510k Number | K943753 |
| Device Name: | FRAME SPECTACLE |
| Classification | Frame, Spectacle |
| Applicant | OPTIC TECH CORP. 5605 N.W. 74TH AVE. Miami, FL 33166 |
| Contact | Agueda M Graupera |
| Correspondent | Agueda M Graupera OPTIC TECH CORP. 5605 N.W. 74TH AVE. Miami, FL 33166 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-09-02 |