FDA 510(k) Application Details - K121048

Device Classification Name Prosthesis, Tracheal, Expandable

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510(K) Number K121048
Device Name Prosthesis, Tracheal, Expandable
Applicant BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact JANIS F TARANTO
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Regulation Number 878.3720

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Classification Product Code JCT
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Date Received 04/06/2012
Decision Date 08/03/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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