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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 K070637
Device Name FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES
Applicant
Paragon Vision Sciences
947 E. Impala Ave.
Mesa,  AZ  85204
Applicant Contact WILLIAM E MEYERS
Correspondent
Paragon Vision Sciences
947 E. Impala Ave.
Mesa,  AZ  85204
Correspondent Contact WILLIAM E MEYERS
Regulation Number886.5916
Classification Product Code
HQD  
Date Received03/07/2007
Decision Date 05/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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