The following data is part of a premarket notification filed by Ningbo Yinzhou Zonghai Artware Co., Ltd. with the FDA for Contact Lens Case.
Device ID | K162869 |
510k Number | K162869 |
Device Name: | Contact Lens Case |
Classification | Case, Contact Lens |
Applicant | Ningbo Yinzhou Zonghai Artware Co., Ltd. Honglianchi, Guangsheng Village, Jishigang Town Yinzhou District Ningbo City, CN 315172 |
Contact | Weng Changhai |
Correspondent | Charles Mack IRC 7808 Rush Creek Drive Pasco, WA 99301 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-13 |
Decision Date | 2016-12-09 |
Summary: | summary |