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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K202280
FOIA Releasable 510(k) K202280
Device Name Cleerly Labs v2.0
Applicant
Cleerly, Inc.
101 Greenwich St, Suite 11C
New York,  NY  10006
Applicant Contact James K. Min
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/11/2020
Decision Date 10/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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