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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 K240205
Device Name Ez Catch Auto; Ez Catch YR; Ez Catch TR
Applicant
Veol Medical Technologies Pvt Ltd.
A 747, MIDC Pawane, TTC Industrial Area, Kopar Khairane
Navi Mumbai,  IN 400705
Applicant Contact Sneha Pandit
Correspondent
Passarini
Rua Alice Além Saadi, Av. Pres. Castelo Branco,
855 - Sala 2404
Ribeirão Preto,  BR 14096-570
Correspondent Contact Bruno Milhoci
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/25/2024
Decision Date 04/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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