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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 K853035
Device Name HESSBURG LIGHT GUARD
Applicant
Visitec Co.
2043 Whitfield Park Dr.
Sarasota,  FL  33580
Applicant Contact THOMAS B GIVENS
Correspondent
Visitec Co.
2043 Whitfield Park Dr.
Sarasota,  FL  33580
Correspondent Contact THOMAS B GIVENS
Regulation Number886.4750
Classification Product Code
HOY  
Date Received07/18/1985
Decision Date 12/13/1985
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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