FDA 510(k) Application Details - K102285

Device Classification Name System, X-Ray, Stationary

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510(K) Number K102285
Device Name System, X-Ray, Stationary
Applicant MEDICATECH USA
8870 RAVELLO COURT
NAPLES, FL 34114 US
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Contact JOHN ROSS
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 08/12/2010
Decision Date 01/03/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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