FDA 510(k) Application Details - K971167

Device Classification Name Probe, Uptake, Nuclear

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510(K) Number K971167
Device Name Probe, Uptake, Nuclear
Applicant NEOPROBE CORP.
425 METRO PLACE NORTH,
STE. 300
DUBLIN, OH 43017 US
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Contact SUSAN D TIEDY-STEVENSON
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Regulation Number 892.1320

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Classification Product Code IZD
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Date Received 03/31/1997
Decision Date 06/26/1997
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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