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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 K082799
Device Name HDS HI 1.54
Applicant
Paragon Vision Sciences
947 E. Impala Ave.
Mesa,  AZ  85204
Applicant Contact WILLIAM MEYERS
Correspondent
Paragon Vision Sciences
947 E. Impala Ave.
Mesa,  AZ  85204
Correspondent Contact WILLIAM MEYERS
Regulation Number886.5916
Classification Product Code
HQD  
Date Received09/23/2008
Decision Date 01/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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