510(k) K001964
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2000
- Date Received
- June 27, 2000
- Clearance Type
- Special
- 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