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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, X-Ray System
510(k) Number K193317
Device Name CoreLite X-Ray Specimen Cabinet
Applicant
Cirdan Imaging Limited
8 Enterprise Crescent, Ballinderry Road
Lisburn,  GB BT28 2BP
Applicant Contact Jenna McGarry
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1680
Classification Product Code
MWP  
Date Received11/29/2019
Decision Date 12/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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