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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 K941829
Device Name SUN FILTERS/SHIELDS
Applicant
Klinger Eye Shields, Inc.
10861 75th St. N.
Largo,  FL  34647
Applicant Contact LARAINE MCALPIN
Correspondent
Klinger Eye Shields, Inc.
10861 75th St. N.
Largo,  FL  34647
Correspondent Contact LARAINE MCALPIN
Regulation Number886.4750
Classification Product Code
HOY  
Date Received04/13/1994
Decision Date 05/17/1994
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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