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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 K140683
Device Name 0180 INTUITION, 0072 PRECISION
Applicant
Arcoma AB
8870 Ravello Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Acroma AB
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received03/18/2014
Decision Date 06/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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