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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 K024164
Device Name COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT
Applicant
Metro Optics, Inc.
623 Glacier Dr.
Grand Junction,  CO  81503
Applicant Contact DEANNA WERBER
Correspondent
Metro Optics, Inc.
623 Glacier Dr.
Grand Junction,  CO  81503
Correspondent Contact DEANNA WERBER
Regulation Number886.5916
Classification Product Code
HQD  
Date Received12/17/2002
Decision Date 02/12/2003
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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