510(k) K994320
K994320 is an FDA 510(k) premarket notification submitted by Cantor & Silver , Ltd. for the device "CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on October 20, 2000. The device falls under product code NCZ (Lens, Contact, For Color Vision Deficiency), a Class II device regulated under 21 CFR 886.5925. Cantor & Silver , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2000
- Date Received
- December 22, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact, For Color Vision Deficiency
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type