The following data is part of a premarket notification filed by Australian Optical Co., Inc. with the FDA for Spectacle Frame.
| Device ID | K943561 |
| 510k Number | K943561 |
| Device Name: | SPECTACLE FRAME |
| Classification | Frame, Spectacle |
| Applicant | AUSTRALIAN OPTICAL CO., INC. 1775 UNIVERSAL AVE. SUITE 1620 Kansas City, MO 64120 |
| Contact | Shari Downing |
| Correspondent | Shari Downing AUSTRALIAN OPTICAL CO., INC. 1775 UNIVERSAL AVE. SUITE 1620 Kansas City, MO 64120 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-22 |
| Decision Date | 1994-09-14 |