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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Fundus, Hruby, Diagnostic
510(k) Number K820223
Device Name OMS QUARTZ INFUSION CONTACT LENS
Applicant
OPTICAL MICRO SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OPTICAL MICRO SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1395
Classification Product Code
HJI  
Date Received01/27/1982
Decision Date 02/05/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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