VISITEC EYE SHIELD

Pad, Eye

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Eye Shield.

Pre-market Notification Details

Device IDK843197
510k NumberK843197
Device Name:VISITEC EYE SHIELD
ClassificationPad, Eye
Applicant VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota,  FL  33580
ContactEugene H. Beckstein
CorrespondentEugene H. Beckstein
VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota,  FL  33580
Product CodeHMP  
CFR Regulation Number878.4440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-14
Decision Date1984-10-05

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