The following data is part of a premarket notification filed by Korea Asahi Optical Co., Ltd. with the FDA for Multiple Spectacle Lens.
Device ID | K871961 |
510k Number | K871961 |
Device Name: | MULTIPLE SPECTACLE LENS |
Classification | Lens, Spectacle, Non-custom (prescription) |
Applicant | KOREA ASAHI OPTICAL CO., LTD. 514-18 SHINSA-DONG GANGNAM-GU Seoul, Korea, KR |
Contact | Yoon, Soo-han |
Correspondent | Yoon, Soo-han KOREA ASAHI OPTICAL CO., LTD. 514-18 SHINSA-DONG GANGNAM-GU Seoul, Korea, KR |
Product Code | HQG |
CFR Regulation Number | 886.5844 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-20 |
Decision Date | 1987-06-03 |