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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K120756
Device Name LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
Applicant
The Lagado Corp.
218 E. Commercial Blvd.
Suite # 201-Q
Lauderdale By The Sea,  FL  33308
Applicant Contact ELLEN BEUCLER
Correspondent
The Lagado Corp.
218 E. Commercial Blvd.
Suite # 201-Q
Lauderdale By The Sea,  FL  33308
Correspondent Contact ELLEN BEUCLER
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/13/2012
Decision Date 05/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT01735045
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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