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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 K221263
Device Name Aqua Naina Plus Sterile Saline Solution
Applicant
Chemtex USA, Inc.
27-29 Dwight Pl.
Fairfield,  NJ  07004
Applicant Contact Haribabu Talasila
Correspondent
Eyereg Consulting, Inc.
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received05/02/2022
Decision Date 10/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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