FDA 510(k) Application Details - K032129

Device Classification Name Wire, Guide, Catheter

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510(K) Number K032129
Device Name Wire, Guide, Catheter
Applicant RADIUS MEDICAL TECHNOLOGIES, INC.
7 TIFFANY TRAIL
HOPKINTON, MA 01748 US
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Contact DEBBIE IAMPIETRO
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 07/10/2003
Decision Date 07/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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