The following data is part of a premarket notification filed by Optipia Trading Co. with the FDA for Spectacle Frame Or Eyeglass Frames.
| Device ID | K945176 |
| 510k Number | K945176 |
| Device Name: | SPECTACLE FRAME OR EYEGLASS FRAMES |
| Classification | Frame, Spectacle |
| Applicant | OPTIPIA TRADING CO. 4TH FLOOR 98-4 WONDAE 2GA SEOGU Daegu, KR 2a Seogu |
| Contact | S T King |
| Correspondent | S T King OPTIPIA TRADING CO. 4TH FLOOR 98-4 WONDAE 2GA SEOGU Daegu, KR 2a Seogu |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-24 |
| Decision Date | 1994-12-15 |