FDA 510(k) Application Details - K960892

Device Classification Name System, Radiation Therapy, Radionuclide

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510(K) Number K960892
Device Name System, Radiation Therapy, Radionuclide
Applicant NOVA THERAPEUTIC SYSTEM
2004 LE DROIT DR.
SOUTH PASADENA, CA 91030 US
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Contact JOSEPH S SHEPHERD
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Regulation Number 892.5750

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Classification Product Code IWB
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Date Received 03/05/1996
Decision Date 06/03/1996
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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