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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K222542
Device Name MCB UNIT Model: V10GMCBUS
Applicant
Lamidey Noury Medical
3 rue des petits ruisseaux
Verriere Le Buisson,  FR 91370
Applicant Contact M. Guillaume Noury
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
GEI  
Date Received08/22/2022
Decision Date 09/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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