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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 K993486
Device Name PARAGON LENS CARRIER
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 Number886.5928
Classification Product Code
LRX  
Date Received10/15/1999
Decision Date 12/22/1999
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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