VITLITE (TR7700)

Endoilluminator

ESCALON TREK MEDICAL

The following data is part of a premarket notification filed by Escalon Trek Medical with the FDA for Vitlite (tr7700).

Pre-market Notification Details

Device IDK963417
510k NumberK963417
Device Name:VITLITE (TR7700)
ClassificationEndoilluminator
Applicant ESCALON TREK MEDICAL 822 SWAN DR. Mukwonago,  WI  53149
ContactRonald L Hueneke
CorrespondentRonald L Hueneke
ESCALON TREK MEDICAL 822 SWAN DR. Mukwonago,  WI  53149
Product CodeMPA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-30
Decision Date1996-12-20

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