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FDA 510(k) Application Details - K101452
Device Classification Name
Calibrator, Dose, Radionuclide
More FDA Info for this Device
510(K) Number
K101452
Device Name
Calibrator, Dose, Radionuclide
Applicant
CAPINTEC, INC.
620 ALPHA DR.
PITTSBURGH, PA 15238 US
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Contact
MARY ANNE DELL
Other 510(k) Applications for this Contact
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
05/25/2010
Decision Date
08/09/2010
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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