The following data is part of a premarket notification filed by Samil Enterprise Co. with the FDA for Spectacle Frame.
| Device ID | K943084 |
| 510k Number | K943084 |
| Device Name: | SPECTACLE FRAME |
| Classification | Frame, Spectacle |
| Applicant | SAMIL ENTERPRISE CO. 120 EAST BALTIMORE ST. Baltimore, MD 21202 -1643 |
| Contact | Peggy Chaplin |
| Correspondent | Peggy Chaplin SAMIL ENTERPRISE CO. 120 EAST BALTIMORE ST. Baltimore, MD 21202 -1643 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-28 |
| Decision Date | 1994-07-25 |