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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 K112373
Device Name CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION
Applicant
INNOVA VISION INC.
2904 N. BOLDT DRIVE
FLAGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
INNOVA VISION INC.
2904 N. BOLDT DRIVE
FLAGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number886.5925
Classification Product Code
LPL  
Date Received08/17/2011
Decision Date 08/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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