FDA 510(k) Application Details - K073419

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K073419
Device Name Device, Neurovascular Embolization
Applicant RJ MEDICAL, INC.
4921 ROBERT J. MATHEWS PKWY
#2
EL DORADO HILLS, CA 95762 US
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Contact JIM INNES
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 12/05/2007
Decision Date 02/14/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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