FDA 510(k) Application Details - K973575

Device Classification Name Prosthesis, Chin, Internal

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510(K) Number K973575
Device Name Prosthesis, Chin, Internal
Applicant HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON, WA 98346 US
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Contact ERIK HANSON
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Regulation Number 878.3550

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Classification Product Code FWP
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Date Received 09/19/1997
Decision Date 11/07/1997
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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