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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Solution, Ultrasonic Cleaners For Lenses
510(k) Number K211361
Device Name 3N Contact Lenses Adjunct Cleaner
Applicant
Suzhou 3N Biological Technology Co., Ltd.
#218 Xinghu St.
Suzhou,  CN 215000
Applicant Contact Yang Bai
Correspondent
Suzhou 3N Biological Technology Co., Ltd.
#218 Xinghu St.
Suzhou,  CN 215000
Correspondent Contact Yang Bai
Regulation Number886.5928
Classification Product Code
LYL  
Date Received05/03/2021
Decision Date 01/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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