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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K210051
Device Name OTE MPS 045 Multi-purpose Lens Care Solution
Applicant
Ote North America, LLC
40 Bayview Ave.
Inwood,  NY  11096
Applicant Contact Nathan Rosenberg
Correspondent
Foresight Regulatory Strategies, Inc.
1820 Turnpike St., Suite 201
North Andover,  MA  01845
Correspondent Contact Ellen M. Beucler
Regulation Number886.5928
Classification Product Code
LPN  
Date Received01/08/2021
Decision Date 05/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT03278223
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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