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FDA 510(k) Application Details - K200021
Device Classification Name
Anoscope And Accessories
More FDA Info for this Device
510(K) Number
K200021
Device Name
Anoscope And Accessories
Applicant
Applied Medical Resources
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
Other 510(k) Applications for this Company
Contact
Frans VandenBroek
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FER
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2020
Decision Date
01/06/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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