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FDA 510(k) Application Details - K010166
Device Classification Name
System, Applicator, Radionuclide, Manual
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510(K) Number
K010166
Device Name
System, Applicator, Radionuclide, Manual
Applicant
IMAGYN MEDICAL TECHNOLOGIES, INC.
8850 M-89
RICHLAND, MI 49083 US
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Contact
JULIE POWELL
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Regulation Number
892.5650
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Classification Product Code
IWJ
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More FDA Info for this Product Code
Date Received
01/18/2001
Decision Date
12/03/2001
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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