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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K212274
Device Name INT Contour
Applicant
Carina Medical LLC
1233 Litchfield Ln
Lexington,  KY  40513
Applicant Contact Xue Feng
Correspondent
Carina Medical LLC
1233 Litchfield Ln
Lexington,  KY  40513
Correspondent Contact Xue Feng
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
QKB  
Date Received07/20/2021
Decision Date 04/08/2022
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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