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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 K120904
Model #202
Device Name POLARIS DIAL-A-DATE CONTACT LENS CASE
Original Applicant
RELIANCE DESIGN & MANUFACTURE CORP.
611 west fifth street
thrid floor
austin,  TX  78701
Original Contact caroline tontini
Regulation Number886.5928
Classification Product Code
LRX  
Date Received03/26/2012
Decision Date 11/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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