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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K131875
Device Name MENICON NECT CONTACT LENS CASE
Applicant
Foresight Regulatory Strategies
187 Ballardvale St.
Suite 180
Wilmington,  MA  01887 -4461
Applicant Contact Ellen M Beucler
Correspondent
Foresight Regulatory Strategies
187 Ballardvale St.
Suite 180
Wilmington,  MA  01887 -4461
Correspondent Contact Ellen M Beucler
Regulation Number886.5928
Classification Product Code
LRX  
Date Received06/24/2013
Decision Date 08/06/2013
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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