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FDA 510(k) Application Details - K961321
Device Classification Name
Probe, Uptake, Nuclear
More FDA Info for this Device
510(K) Number
K961321
Device Name
Probe, Uptake, Nuclear
Applicant
RADIATION MONITORING DEVICES, INC.
44 HUNT ST.
WATERTOWN, MA 02472-4699 US
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Contact
PAUL STOPPEL
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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
04/05/1996
Decision Date
02/10/1997
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
FDA Source Information for K961321
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