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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, nose, internal
510(k) Number K071018
Device Name MONARCH NASAL IMPLANT
Applicant
HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON,  WA  98346
Applicant Contact GERALD HANSON
Correspondent
HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON,  WA  98346
Correspondent Contact GERALD HANSON
Regulation Number878.3680
Classification Product Code
FZE  
Date Received04/10/2007
Decision Date 05/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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