OTE MPS 045 Multi-purpose Lens Care Solution

Accessories, Soft Lens Products

OTE North America LLC

The following data is part of a premarket notification filed by Ote North America Llc with the FDA for Ote Mps 045 Multi-purpose Lens Care Solution.

Pre-market Notification Details

Device IDK210051
510k NumberK210051
Device Name:OTE MPS 045 Multi-purpose Lens Care Solution
ClassificationAccessories, Soft Lens Products
Applicant OTE North America LLC 40 Bayview Ave Inwood,  NY  11096
ContactNathan Rosenberg
CorrespondentEllen M. Beucler
Foresight Regulatory Strategies, Inc. 1820 Turnpike Street, Suite 201 North Andover,  MA  01845
Product CodeLPN  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-08
Decision Date2021-05-26

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