FDA 510(k) Application Details - K071018

Device Classification Name Prosthesis, Nose, Internal

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510(K) Number K071018
Device Name Prosthesis, Nose, Internal
Applicant HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON, WA 98346 US
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Contact GERALD HANSON
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Regulation Number 878.3680

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Classification Product Code FZE
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Date Received 04/10/2007
Decision Date 05/25/2007
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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