FDA 510(k) Application Details - K961321

Device Classification Name Probe, Uptake, Nuclear

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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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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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