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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 K980197
Device Name ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR
Applicant
Specialty Ultravision, Inc.
307 Orchard City Dr.
Suite 100
Campbell,  CA  95008
Applicant Contact IVALEE I COHEN
Correspondent
Specialty Ultravision, Inc.
307 Orchard City Dr.
Suite 100
Campbell,  CA  95008
Correspondent Contact IVALEE I COHEN
Regulation Number886.5916
Classification Product Code
HQD  
Date Received01/20/1998
Decision Date 08/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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