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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lens, contact (other material) - daily
510(k) Number K120996
Device Name FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
Original Applicant
PARAGON VISION SCIENCES
947 east impala ave.
mesa,  AZ  85204
Original Contact william e meyers
Regulation Number886.5916
Classification Product Code
HQD  
Date Received04/02/2012
Decision Date 06/28/2012
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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