The following data is part of a premarket notification filed by Kookje Apis Industrial Co. with the FDA for Frame, Spectacle.
| Device ID | K945450 |
| 510k Number | K945450 |
| Device Name: | FRAME, SPECTACLE |
| Classification | Frame, Spectacle |
| Applicant | KOOKJE APIS INDUSTRIAL CO. ROOM 600 120-13 SOSOMOONTONG CHOONG-KU Seoul, KR |
| Contact | Haetong Sohn |
| Correspondent | Haetong Sohn KOOKJE APIS INDUSTRIAL CO. ROOM 600 120-13 SOSOMOONTONG CHOONG-KU Seoul, 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 | 1994-11-22 |