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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 K140869
Device Name DCAS I
Applicant
GP&P CO., LTD.
12226 WASHINGTON LANE
parker,  AZ  85344
Applicant Contact charlie mack
Correspondent
GP&P CO., LTD.
12226 WASHINGTON LANE
parker,  AZ  85344
Correspondent Contact charlie mack
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/03/2014
Decision Date 07/03/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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