The following data is part of a premarket notification filed by Amcon Laboratories, Inc. with the FDA for Amcon Slip In Mydriatic Sunglasses.
| Device ID | K942407 |
| 510k Number | K942407 |
| Device Name: | AMCON SLIP IN MYDRIATIC SUNGLASSES |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | AMCON LABORATORIES, INC. 19916 SE 19TH ST. Issaquah, WA 98027 |
| Contact | Andrea R Friedman |
| Correspondent | Andrea R Friedman AMCON LABORATORIES, INC. 19916 SE 19TH ST. Issaquah, WA 98027 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-20 |
| Decision Date | 1994-06-06 |