FDA 510(k) Application Details - K030947

Device Classification Name Prosthesis, Tracheal, Expandable

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510(K) Number K030947
Device Name Prosthesis, Tracheal, Expandable
Applicant ALVEOLUS, INC.
9013 PERIMETER WOODS SUITE A
CHARLOTTE, NC 28216 US
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Contact HOWARD L SCHRAYER
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Regulation Number 878.3720

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Classification Product Code JCT
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Date Received 03/26/2003
Decision Date 05/15/2003
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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