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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, Stationary
510(k) Number K161937
Device Name CuattroDR
Applicant
Cuattro, LLC
3760 Rocky Mountain Avenue
Loveland,  CO  80538
Applicant Contact Matthew Taylor
Correspondent
Cuattro, LLC
3760 Rocky Mountain Avenue
Loveland,  CO  80538
Correspondent Contact Matthew Taylor
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
LLZ  
Date Received07/14/2016
Decision Date 10/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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