HESSBURG LIGHT GUARD

Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Hessburg Light Guard.

Pre-market Notification Details

Device IDK853035
510k NumberK853035
Device Name:HESSBURG LIGHT GUARD
ClassificationShield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Applicant VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota,  FL  33580
ContactThomas B Givens
CorrespondentThomas B Givens
VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota,  FL  33580
Product CodeHOY  
CFR Regulation Number886.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-18
Decision Date1985-12-13

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