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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 K112832
Device Name EYE CARE CURE CONTACT LENS CASE
Original Applicant
EYE CARE AND CURE
4646 s overland dr
tucson,  AZ  85714
Original Contact lindy v dalen
Regulation Number886.5928
Classification Product Code
LRX  
Date Received09/29/2011
Decision Date 12/05/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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