FDA 510(k) Application Details - K071457

Device Classification Name Device, Percutaneous Retrieval

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510(K) Number K071457
Device Name Device, Percutaneous Retrieval
Applicant RADIUS MEDICAL TECHNOLOGIES, INC.
15 CRAIG ROAD
ACTON, MA 01720 US
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Contact MAUREEN FINLAYSON
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Regulation Number 870.5150

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Classification Product Code MMX
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Date Received 05/25/2007
Decision Date 09/25/2007
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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