OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

Accessories, Soft Lens Products

ALCON UNIVERSAL, LTD.

The following data is part of a premarket notification filed by Alcon Universal, Ltd. with the FDA for Opti-free Express Multi-purpose Disinfecting Solution.

Pre-market Notification Details

Device IDK021143
510k NumberK021143
Device Name:OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
ClassificationAccessories, Soft Lens Products
Applicant ALCON UNIVERSAL, LTD. 6201 SOUTH FREEWAY Fort Worth,  TX  76134 -2099
ContactRalph H Larsen
CorrespondentRalph H Larsen
ALCON UNIVERSAL, LTD. 6201 SOUTH FREEWAY Fort Worth,  TX  76134 -2099
Product CodeLPN  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-09
Decision Date2002-08-08
Summary:summary

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