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FDA 510(k) Application Details - K973573
Device Classification Name
Prosthesis, Nose, Internal
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510(K) Number
K973573
Device Name
Prosthesis, Nose, Internal
Applicant
HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON, WA 98346 US
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HUDSON
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Regulation Number
878.3680
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Classification Product Code
FZE
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More FDA Info for this Product Code
Date Received
09/19/1997
Decision Date
11/13/1997
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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