The following data is part of a premarket notification filed by Seo Han Corp., Ltd. with the FDA for Spectacle Frame.
| Device ID | K945392 |
| 510k Number | K945392 |
| Device Name: | SPECTACLE FRAME |
| Classification | Frame, Spectacle |
| Applicant | SEO HAN CORP., LTD. 5L 26B, DALSEO KOO, SEONG SEO INDUSTRIAL ESTATE, 2CHA 1JIKOO Daegu, KR |
| Contact | S K Bae |
| Correspondent | S K Bae SEO HAN CORP., LTD. 5L 26B, DALSEO KOO, SEONG SEO INDUSTRIAL ESTATE, 2CHA 1JIKOO Daegu, KR |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-03 |
| Decision Date | 1994-12-15 |