The following data is part of a premarket notification filed by Sunny Union Industrial Co., Ltd. with the FDA for Spectacle Frames.
Device ID | K943442 |
510k Number | K943442 |
Device Name: | SPECTACLE FRAMES |
Classification | Frame, Spectacle |
Applicant | SUNNY UNION INDUSTRIAL CO., LTD. P.O. BOX 53-1105, 4F, NO. 39 LANE 131 YEN - CHI STREET Taipei, TW |
Contact | Teddy Wang |
Correspondent | Teddy Wang SUNNY UNION INDUSTRIAL CO., LTD. P.O. BOX 53-1105, 4F, NO. 39 LANE 131 YEN - CHI STREET Taipei, TW |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-18 |
Decision Date | 1994-08-02 |