FDA 510(k) Application Details - K071392

Device Classification Name System, X-Ray, Stationary

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510(K) Number K071392
Device Name System, X-Ray, Stationary
Applicant SOURCE-RAY, INC.
167 KEYLAND CT.
BOHEMIA, NY 11716 US
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Contact RAY MANEZ
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 05/18/2007
Decision Date 08/03/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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