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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 K122697
Device Name PORTA 100HF
Original Applicant
JOB CORPORATION
1411 w. 190th street
suite 120
gardena,  CA  92048
Original Contact takahiro haruyama
Regulation Number892.1720
Classification Product Code
IZL  
Date Received09/04/2012
Decision Date 10/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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