NEW COMFORT CONTACT LENS CARE ACCESSORY

Accessories, Solution, Ultrasonic Cleaners For Lenses

LENS COMFORT, INC.

The following data is part of a premarket notification filed by Lens Comfort, Inc. with the FDA for New Comfort Contact Lens Care Accessory.

Pre-market Notification Details

Device IDK962112
510k NumberK962112
Device Name:NEW COMFORT CONTACT LENS CARE ACCESSORY
ClassificationAccessories, Solution, Ultrasonic Cleaners For Lenses
Applicant LENS COMFORT, INC. 912 BROAD ST. Elizabeth,  NJ  07208
ContactJames Demestichas
CorrespondentJames Demestichas
LENS COMFORT, INC. 912 BROAD ST. Elizabeth,  NJ  07208
Product CodeLYL  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-31
Decision Date1996-11-29
Summary:summary

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