CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
FDA 510(k) clearance K022373 · decided 2002-10-07
Clearance details
- K-number
- K022373
- Device name
- CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
- Applicant
- Cantor & Nissel , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-22
- Decision date
- 2002-10-07
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- NJH
- Device class
- 1
- Regulation number
- 886.5844
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Grand Junction, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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| PY-RITE (K853758) | Golden Dental Products, Inc. | 1985-12-03 |
Recalls involving this device
No recalls on record reference this clearance.