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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 K973573
Device Name DURALASTIC ANATOMICAL NASAL IMPLANTS
Applicant
HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON,  WA  98346
Applicant Contact HUDSON
Correspondent
HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON,  WA  98346
Correspondent Contact HUDSON
Regulation Number878.3680
Classification Product Code
FZE  
Date Received09/19/1997
Decision Date 11/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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