EG-3870UTK

Endoscopic Ultrasound System, Gastroenterology-urology

PENTAX MEDICAL COMPANY

The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Eg-3870utk.

Pre-market Notification Details

Device IDK090197
510k NumberK090197
Device Name:EG-3870UTK
ClassificationEndoscopic Ultrasound System, Gastroenterology-urology
Applicant PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE RD. Montvale,  NJ  07645 -1856
ContactPaul Silva
CorrespondentPaul Silva
PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE RD. Montvale,  NJ  07645 -1856
Product CodeODG  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-27
Decision Date2009-05-19
Summary:summary

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