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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 Dr. 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
Predetermined Change
Control Plan Authorized		 No
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