APPLIED URETERAL CATHETER

Catheter, Ureteral, Gastro-urology

APPLIED MEDICAL RESOURCES CORP.

The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Applied Ureteral Catheter.

Pre-market Notification Details

Device IDK020577
510k NumberK020577
Device Name:APPLIED URETERAL CATHETER
ClassificationCatheter, Ureteral, Gastro-urology
Applicant APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactAnil Bhalani
CorrespondentAnil Bhalani
APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeEYB  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-21
Decision Date2002-05-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.