MONARCH IOL DELIVERY SYSTEM

Lens, Guide, Intraocular

ALCON LABORATORIES

The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Monarch Iol Delivery System.

Pre-market Notification Details

Device IDK970033
510k NumberK970033
Device Name:MONARCH IOL DELIVERY SYSTEM
ClassificationLens, Guide, Intraocular
Applicant ALCON LABORATORIES 6201 S FREEWAY Ft Worth,  TX  76134
ContactMartin A Kaufman
CorrespondentMartin A Kaufman
ALCON LABORATORIES 6201 S FREEWAY Ft Worth,  TX  76134
Product CodeKYB  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-03
Decision Date1997-04-23
Summary:summary

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