ADVANCED UROSCIENCE INNERSHEATH

Endoscopic Injection Needle, Gastroenterology-urology

ADVANCED UROSCIENCE, INC.

The following data is part of a premarket notification filed by Advanced Uroscience, Inc. with the FDA for Advanced Uroscience Innersheath.

Pre-market Notification Details

Device IDK002573
510k NumberK002573
Device Name:ADVANCED UROSCIENCE INNERSHEATH
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant ADVANCED UROSCIENCE, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
ContactKaren E Peterson
CorrespondentKaren E Peterson
ADVANCED UROSCIENCE, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-18
Decision Date2000-11-16
Summary:summary

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