ALCON SITE(R)-COMPATIBLE CASSETTE

Device, Irrigation, Ocular Surgery

ALCON LABORATORIES

The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Site(r)-compatible Cassette.

Pre-market Notification Details

Device IDK881682
510k NumberK881682
Device Name:ALCON SITE(R)-COMPATIBLE CASSETTE
ClassificationDevice, Irrigation, Ocular Surgery
Applicant ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth,  TX  76134 -2099
ContactRebecca G Walkers
CorrespondentRebecca G Walkers
ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth,  TX  76134 -2099
Product CodeKYG  
CFR Regulation Number886.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-19
Decision Date1988-07-01

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