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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
MZD  
Date Received06/14/1999
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
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