LEVIGATOR, KEELER PHOKO

Unit, Phacofragmentation

KEELER OPTICAL PRODUCTS LTD.

The following data is part of a premarket notification filed by Keeler Optical Products Ltd. with the FDA for Levigator, Keeler Phoko.

Pre-market Notification Details

Device IDK782141
510k NumberK782141
Device Name:LEVIGATOR, KEELER PHOKO
ClassificationUnit, Phacofragmentation
Applicant KEELER OPTICAL PRODUCTS LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-27
Decision Date1979-01-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.