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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K863182
Device Name EYE BARRIER
Applicant
O.R. Concepts, Inc.
200 N. Oak St.
Roanoke,  TX  76262
Applicant Contact JOE A STALEY
Correspondent
O.R. Concepts, Inc.
200 N. Oak St.
Roanoke,  TX  76262
Correspondent Contact JOE A STALEY
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/19/1986
Decision Date 09/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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