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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 K171677
Device Name Clear Guide SCENERGY
Applicant
Clear Guide Medical
3600 Clipper Mill Road, Suite 400
Baltimore,  MD  21211
Applicant Contact Jack Kent
Correspondent
Clear Guide Medical
3600 Clipper Mill Road, Suite 400
Baltimore,  MD  21211
Correspondent Contact Dorothee Heisenberg
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/06/2017
Decision Date 12/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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