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FDA 510(k) Application Details - K132294
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
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More FDA Info for this Product Code
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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