The following data is part of a premarket notification filed by Korea Asahi Optical Co., Ltd. with the FDA for Classic 70 Lens.
Device ID | K871649 |
510k Number | K871649 |
Device Name: | CLASSIC 70 LENS |
Classification | Unit, Phacofragmentation |
Applicant | KOREA ASAHI OPTICAL CO., LTD. 135 WEST 27TH ST. New York, NY 10001 |
Contact | Murray Green |
Correspondent | Murray Green KOREA ASAHI OPTICAL CO., LTD. 135 WEST 27TH ST. New York, NY 10001 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-29 |
Decision Date | 1987-05-29 |