FDA 510(k) Application Details - K982184

Device Classification Name Prosthesis, Tracheal, Expandable

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510(K) Number K982184
Device Name Prosthesis, Tracheal, Expandable
Applicant BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS, MN 55442 US
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Contact PHILIP B JARVI
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Regulation Number 878.3720

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Classification Product Code JCT
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Date Received 06/22/1998
Decision Date 07/21/1998
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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