The following data is part of a premarket notification filed by Europa Continental, Inc. with the FDA for Optical Frames.
| Device ID | K936004 |
| 510k Number | K936004 |
| Device Name: | OPTICAL FRAMES |
| Classification | Frame, Spectacle |
| Applicant | EUROPA CONTINENTAL, INC. 56 FUHRMAN AVE. Ramsey, NJ 07446 |
| Contact | Sang K Han |
| Correspondent | Sang K Han EUROPA CONTINENTAL, INC. 56 FUHRMAN AVE. Ramsey, NJ 07446 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-15 |
| Decision Date | 1994-02-22 |