FDA 510(k) Application Details - K023811

Device Classification Name Prosthesis, Tracheal, Expandable

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510(K) Number K023811
Device Name Prosthesis, Tracheal, Expandable
Applicant W.L. GORE & ASSOCIATES,INC
3750 WEST KILTIE LN.
P.O. BOX 900
FLAGSTAFF, AZ 86002-0900 US
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Contact TIMOTHY J RYNN
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Regulation Number 878.3720

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Classification Product Code JCT
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Date Received 11/15/2002
Decision Date 12/10/2002
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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