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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K234030
Device Name Clear Guide SCENERGY
Applicant
Clear Guide Medical
3600 Clipper Mill Road, Suite 400
Baltimore,  MD  21211
Applicant Contact Alican Demir
Correspondent
Clear Guide Medical
3600 Clipper Mill Road, Suite 400
Baltimore,  MD  21211
Correspondent Contact Alican Demir
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Codes
ITX   IYO   LLZ  
Date Received12/20/2023
Decision Date 01/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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