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FDA 510(k) Application Details - K953946
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
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510(K) Number
K953946
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
NUCLETRON-OLDELFT CORP.
7080 COLUMBIA GATEWAY DR.
COLUMBIA, MD 21046-2119 US
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Contact
STEPHEN P TEAGUE
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Regulation Number
892.5700
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Classification Product Code
JAQ
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More FDA Info for this Product Code
Date Received
08/21/1995
Decision Date
08/13/1996
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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