SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS

System, In-office Tinting, Contact Lenses

SOFTCHROME, INC.

The following data is part of a premarket notification filed by Softchrome, Inc. with the FDA for Softchrome Tints, Transparent Tinted Soft Contact Lens.

Pre-market Notification Details

Device IDK991995
510k NumberK991995
Device Name:SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
ClassificationSystem, In-office Tinting, Contact Lenses
Applicant SOFTCHROME, INC. 623 GLACIER DR. Grand Junction,  CO  81503
ContactMartin Dalsing
CorrespondentMartin Dalsing
SOFTCHROME, INC. 623 GLACIER DR. Grand Junction,  CO  81503
Product CodeMZD  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-14
Decision Date1999-08-27
Summary:summary

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