The following data is part of a premarket notification filed by Sun Hing Optical Manufactory Ltd. with the FDA for Spectacle Frame.
| Device ID | K944313 |
| 510k Number | K944313 |
| Device Name: | SPECTACLE FRAME |
| Classification | Frame, Spectacle |
| Applicant | SUN HING OPTICAL MANUFACTORY LTD. UNIT 1001C 10/F SUNBEAM CENTER 27 SHING YIP ST Kwun Tong, Kowloon, Hong Kong, HK |
| Contact | Phyllis Ku |
| Correspondent | Phyllis Ku SUN HING OPTICAL MANUFACTORY LTD. UNIT 1001C 10/F SUNBEAM CENTER 27 SHING YIP ST Kwun Tong, Kowloon, Hong Kong, HK |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1995-03-28 |