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FDA 510(k) Application Details - K121410
Device Classification Name
System, X-Ray, Mobile
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510(K) Number
K121410
Device Name
System, X-Ray, Mobile
Applicant
SEDECAL SA
8870 RAVELLO ST
NAPLES, FL 34114 US
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Contact
DANIEL KAMM
Other 510(k) Applications for this Contact
Regulation Number
892.1720
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Classification Product Code
IZL
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More FDA Info for this Product Code
Date Received
05/11/2012
Decision Date
08/02/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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