FDA 510(k) Application Details - K132294

Device Classification Name System, X-Ray, Stationary

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510(K) Number K132294
Device Name System, X-Ray, Stationary
Applicant RADIOLOGY SOLUTIONS LLC
8870 RAVELLO CT
NAPLES, FL 34114 US
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Contact DANIEL KAMM
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 07/23/2013
Decision Date 11/12/2013
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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