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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 K121030
Device Name SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
Original Applicant
SACKS HOLDINGS, INC.
p.o. box 676211
rancho santa fe,  CA  92067
Original Contact devin chodorow
Regulation Number886.5928
Classification Product Code
LRX  
Date Received04/05/2012
Decision Date 07/06/2012
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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