The following data is part of a premarket notification filed by Sunny Optical Co., Ltd. with the FDA for Sunny Sun Magnifying Glasses.
Device ID | K852830 |
510k Number | K852830 |
Device Name: | SUNNY SUN MAGNIFYING GLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | SUNNY OPTICAL CO., LTD. Y40 PEI IUN ROAD C Taichung, Taiwan, TW |
Contact | Hwang |
Correspondent | Hwang SUNNY OPTICAL CO., LTD. Y40 PEI IUN ROAD C Taichung, Taiwan, TW |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-02 |
Decision Date | 1985-08-08 |