FDA 510(k) Application Details - K021901

Device Classification Name Prosthesis, Tracheal, Expandable

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510(K) Number K021901
Device Name Prosthesis, Tracheal, Expandable
Applicant BOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311 US
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Contact SHERRY L SPARROW
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Regulation Number 878.3720

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Classification Product Code JCT
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Date Received 06/10/2002
Decision Date 07/09/2002
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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