CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
FDA 510(k) clearance K994320 · decided 2000-10-20
Clearance details
- K-number
- K994320
- Device name
- CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
- Applicant
- Cantor & Silver , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-22
- Decision date
- 2000-10-20
- Days to decision
- 303 days
- Clearance type
- Traditional
- Product code
- NCZ
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Grand Junction, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cantor & Silver
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.