CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS


Device Classification Name

lens, spectacle (prescription), for reading discomfort

510(k) Number K022373
Device Name CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
Original Applicant
CANTOR & NISSEL LTD.
623 glacier dr.
grand juction, 
CO 
81503

Original Contact martin dalsing
Regulation Number 886.5844
Classification Product Code
NJH  
Subsequent Product Codes
HQG   NAI  
Date Received 07/22/2002
Decision Date 10/07/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No