SOLO-CARE BRAND HARD SOLUTION

Products, Contact Lens Care, Rigid Gas Permeable

CIBA VISION CORPORATION

The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Solo-care Brand Hard Solution.

Pre-market Notification Details

Device IDK000607
510k NumberK000607
Device Name:SOLO-CARE BRAND HARD SOLUTION
ClassificationProducts, Contact Lens Care, Rigid Gas Permeable
Applicant CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth,  GA  30097
ContactSteven Dowdley
CorrespondentSteven Dowdley
CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth,  GA  30097
Product CodeMRC  
CFR Regulation Number886.5918 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-23
Decision Date2000-05-15

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