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FDA 510(k) Application Details - K962319
Device Classification Name
Probe, Uptake, Nuclear
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510(K) Number
K962319
Device Name
Probe, Uptake, Nuclear
Applicant
NEOPROBE CORP.
425 METRO PLACE NORTH,
STE. 300
DUBLIN, OH 43017 US
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Contact
SUSAN TIEDY-STEVENSON
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Regulation Number
892.1320
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Classification Product Code
IZD
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More FDA Info for this Product Code
Date Received
06/17/1996
Decision Date
09/13/1996
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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