AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION

Accessories, Soft Lens Products

CIBA VISION CORPORATION

The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Aosept Plus Cleaning And Disinfecting Solution.

Pre-market Notification Details

Device IDK003345
510k NumberK003345
Device Name:AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
ClassificationAccessories, Soft Lens Products
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 CodeLPN  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-25
Decision Date2001-03-26

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