FDA 510(k) Application Details - K051374

Device Classification Name Wire, Guide, Catheter

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510(K) Number K051374
Device Name Wire, Guide, Catheter
Applicant STEREOTAXIS, INC.
4041 FOREST PARK AVE.
ST. LOUIS, MO 63108 US
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Contact KELLY ROWLAND
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 05/26/2005
Decision Date 06/23/2005
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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