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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K241275
Device Name Histolog® Scanner (Hardware 2.4, Software 3.3)
Applicant
Samantree Medical Sa
Ave. De Provence 12
Lausanne,  CH 1007
Applicant Contact Olivier Delporte
Correspondent
Domecus Consulting Services, LLC
1171 Barroilhet Dr.
Hillsboroguh,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number876.1500
Classification Product Code
OWN  
Date Received05/06/2024
Decision Date 08/19/2024
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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