FDA 510(k) Application Details - K050832

Device Classification Name Prosthesis, Tracheal, Expandable

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510(K) Number K050832
Device Name Prosthesis, Tracheal, Expandable
Applicant BARD PERIPHERAL VASCULAR, INC.
P.O. BOX 1740
TEMPE, AZ 85280-1740 US
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Contact DENNIS SALZMANN
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Regulation Number 878.3720

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Classification Product Code JCT
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Date Received 04/01/2005
Decision Date 07/07/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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