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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 K110835
Device Name GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
Applicant
GEO MEDICAL CO., LTD.
27001 LA PAZ ROAD
SUITE 312
MISSION VIEJO,  CA  92691
Applicant Contact ALBERT REGO
Correspondent
GEO MEDICAL CO., LTD.
27001 LA PAZ ROAD
SUITE 312
MISSION VIEJO,  CA  92691
Correspondent Contact ALBERT REGO
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/25/2011
Decision Date 04/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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