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FDA 510(k) Application Details - K152767
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K152767
Device Name
System, X-Ray, Stationary
Applicant
DEL MEDICAL, INC.
241 COVINGTON DR.
BLOOMINGDALE, IL 60108 US
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Contact
JOHN HARTZELL
Other 510(k) Applications for this Contact
Regulation Number
892.1680
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Classification Product Code
KPR
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More FDA Info for this Product Code
Date Received
09/24/2015
Decision Date
12/14/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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