FDA 510(k) Application Details - K991540

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K991540
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact TERI JUCKETT
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 05/03/1999
Decision Date 09/29/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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