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FDA 510(k) Application Details - K973037
Device Classification Name
System, Applicator, Radionuclide, Manual
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510(K) Number
K973037
Device Name
System, Applicator, Radionuclide, Manual
Applicant
AVID N.I.T., INC.
390 SCARLET BLVD.
OLDSMAR, FL 34677 US
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Contact
JOSEPH E HARMS
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Regulation Number
892.5650
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Classification Product Code
IWJ
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Date Received
08/14/1997
Decision Date
01/27/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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