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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K894720
Device Name UNIVERSAL EYESHIELD
Applicant
Trident Medical Products, Inc.
308 S. Henderson
Fort Worth,  TX  76104
Applicant Contact DAN E BRUHL
Correspondent
Trident Medical Products, Inc.
308 S. Henderson
Fort Worth,  TX  76104
Correspondent Contact DAN E BRUHL
Regulation Number886.4750
Classification Product Code
HOY  
Date Received07/25/1989
Decision Date 09/14/1989
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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