510(k) K182984
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2019
- Date Received
- October 29, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Products, Contact Lens Care, Rigid Gas Permeable
- Device Class
- Class II
- Regulation Number
- 886.5918
- Review Panel
- OP
- Submission Type