The following data is part of a premarket notification filed by Sciara Intl., Inc. with the FDA for Spectacle Frame.
| Device ID | K920170 |
| 510k Number | K920170 |
| Device Name: | SPECTACLE FRAME |
| Classification | Frame, Spectacle |
| Applicant | SCIARA INTL., INC. 182-08 149TH AVE. Springfield Gardens, NY 11413 |
| Contact | Marilyn Mahler |
| Correspondent | Marilyn Mahler SCIARA INTL., INC. 182-08 149TH AVE. Springfield Gardens, NY 11413 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-13 |
| Decision Date | 1992-03-11 |