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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 K133959
Device Name PODIATRY X-RAY SYSTEM
Applicant
SOURCE-RAY, INC.
50 Fleetwood Ct
Ronkonkoma,  NY  11779
Applicant Contact Daniel Kamm
Correspondent
SOURCE-RAY, INC.
50 Fleetwood Ct
Ronkonkoma,  NY  11779
Correspondent Contact Daniel Kamm
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received12/24/2013
Decision Date 01/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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