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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 K090803
Device Name HANSON MEDICAL FACIAL IMPLANTS
Applicant
Hanson Medical, Inc.
2706 Wash Blvd.
P.O. Box 1160
Kingston,  WA  98346
Applicant Contact GERALD HANSON
Correspondent
Hanson Medical, Inc.
2706 Wash Blvd.
P.O. Box 1160
Kingston,  WA  98346
Correspondent Contact GERALD HANSON
Regulation Number878.3680
Classification Product Code
FZE  
Subsequent Product Code
LZK  
Date Received03/24/2009
Decision Date 06/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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