The following data is part of a premarket notification filed by Ni Hau Industrial Co., Ltd. with the FDA for Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case.
Device ID | K142717 |
510k Number | K142717 |
Device Name: | Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case |
Classification | Case, Contact Lens |
Applicant | Ni Hau Industrial Co., Ltd. No. 15, Alley 125, Lane 318, Section 2, An Ho Road Tainan City, TW 70967 |
Contact | Lyn Chiu |
Correspondent | Lyn Chiu Ni Hau Industrial Co., Ltd. No. 15, Alley 125, Lane 318, Section 2, An Ho Road Tainan City, TW 70967 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-23 |
Decision Date | 2015-05-07 |
Summary: | summary |