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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 K974636
Device Name FLOSI RIGID GAS PERMEABLE CONTACT LENS
Applicant
FUTURISTIC DESIGN ASSOC.
ONE AVALON RD.
P.O. BOX 1009
MOUNT VERNON,  OH  43050
Applicant Contact WILLIAM PLATT
Correspondent
FUTURISTIC DESIGN ASSOC.
ONE AVALON RD.
P.O. BOX 1009
MOUNT VERNON,  OH  43050
Correspondent Contact WILLIAM PLATT
Regulation Number886.5916
Classification Product Code
HQD  
Date Received12/12/1997
Decision Date 03/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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