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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K231422
Device Name Precision GI
Applicant
Limaca Medical Ltd
3 Ha'Rimon street
Mevo-Carmel Science and Industry Park
En Ha'Emeq,  IL 1925000
Applicant Contact Assaf Klein
Correspondent
SFADC LLC
2425 L Street NW, Apt 307
Washington,  DC  20037
Correspondent Contact Susan Alpert
Regulation Number876.1075
Classification Product Code
FCG  
Date Received05/17/2023
Decision Date 08/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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