Applied Medical Anoscope

Anoscope And Accessories

Applied Medical Resources

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

Pre-market Notification Details

Device IDK200021
510k NumberK200021
Device Name:Applied Medical Anoscope
ClassificationAnoscope And Accessories
Applicant Applied Medical Resources 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactFrans Vandenbroek
CorrespondentAeree Lee
Applied Medical Resources 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeFER  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-06
Decision Date2021-01-06

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