LOW VISION ENHANCEMENT SYSTEM (LVES)

Aid, Vision, Electronic, Battery-powered

TRIANGLE INVESTMENTS

The following data is part of a premarket notification filed by Triangle Investments with the FDA for Low Vision Enhancement System (lves).

Pre-market Notification Details

Device IDK910124
510k NumberK910124
Device Name:LOW VISION ENHANCEMENT SYSTEM (LVES)
ClassificationAid, Vision, Electronic, Battery-powered
Applicant TRIANGLE INVESTMENTS 1629 THAMES ST. 3RD FLOOR Baltimore,  MD  21231
ContactLeigh R Abts
CorrespondentLeigh R Abts
TRIANGLE INVESTMENTS 1629 THAMES ST. 3RD FLOOR Baltimore,  MD  21231
Product CodeHPG  
CFR Regulation Number886.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-11
Decision Date1991-04-10

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