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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 K151768
Device Name Menicon Saline Rinse Solution
Applicant
Menicon Co, Ltd.
21-19, Aoi 3-Chome, Naka-Ku
Nagoya,  JP 460-0006
Applicant Contact TOHRU KAWAGUCHI
Correspondent
Foresight Regulatory Strategies, Inc.
187 Ballardvale St., Suite 180
Wilmington,  MA  01887
Correspondent Contact ELLEN M BEUCLER
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received06/30/2015
Decision Date 08/28/2015
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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