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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K211043
Device Name Alexis Contained Extraction System
Applicant
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact Apeksha Shanbhag
Correspondent
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact Apeksha Shanbhag
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/08/2021
Decision Date 03/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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