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FDA 510(k) Application Details - K013548
Device Classification Name
Calibrator, Dose, Radionuclide
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510(K) Number
K013548
Device Name
Calibrator, Dose, Radionuclide
Applicant
STANDARD IMAGING, INC.
7601 MURPHY DR.
MIDDLETON, WI 53562-2766 US
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Contact
RAYMOND RIDDLE
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Regulation Number
892.1360
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Classification Product Code
KPT
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More FDA Info for this Product Code
Date Received
10/24/2001
Decision Date
11/09/2001
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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