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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 K143474
Device Name Artemis Hand Held Imaging System
Applicant
Quest Medical Imaging
Industrieweg 41
Middenmeer,  NL 1775 PW
Applicant Contact MARTIN HEUVELMANS
Correspondent
Quest Medical Imaging
Industrieweg 41
Middenmeer,  NL 1775 PW
Correspondent Contact MARTIN HEUVELMANS
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Code
GCJ  
Date Received12/05/2014
Decision Date 06/30/2015
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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