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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 K232880
Device Name Inzii Ripstop Redeployable Retrieval System
Applicant
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact Niharika Niranjan Mirji
Correspondent
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact Niharika Niranjan Mirji
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/18/2023
Decision Date 11/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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