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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, Mobile
510(k) Number K100449
Device Name MINXRAY MODEL CMDR-2S
Applicant
Minxray, Inc.
8726 Ferrara Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM, P.E.
Correspondent
Minxray, Inc.
8726 Ferrara Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM, P.E.
Regulation Number892.1720
Classification Product Code
IZL  
Date Received02/17/2010
Decision Date 04/23/2010
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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