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 IDK981571
510k NumberK981571
Device Name:MONARCH IOL DELIVERY SYSTEM
ClassificationLens, Guide, Intraocular
Applicant ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
ContactMartin A Kaufman
CorrespondentMartin A Kaufman
ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
Product CodeKYB  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-04
Decision Date1998-07-09
Summary:summary

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