510(k) K142717
K142717 is an FDA 510(k) premarket notification submitted by Ni Hau Industrial Co., Ltd. for the device "Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case". The FDA issued a decision of Substantially Equivalent on May 7, 2015. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2015
- Date Received
- September 23, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Case, Contact Lens
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type