SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS


Device Classification Name

system,in-office tinting,contact lenses

510(k) Number K991995
Device Name SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
Applicant
SOFTCHROME, INC.
623 glacier dr.
grand junction, 
CO 
81503

Applicant Contact martin dalsing
Correspondent
SOFTCHROME, INC.
623 glacier dr.
grand junction, 
CO 
81503

Correspodent Contact martin dalsing
Regulation Number 886.5925
Classification Product Code
MZD  
Date Received 06/14/1999
Decision Date 08/27/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No