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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 K904350
Device Name CUI DORSAL COLUMELLA PROSTHESIS
Applicant
CUI CORP.
P.O. BOX 40288
SANTA BARBARA,  CA  93140
Applicant Contact MORRIS SHERWOOD
Correspondent
CUI CORP.
P.O. BOX 40288
SANTA BARBARA,  CA  93140
Correspondent Contact MORRIS SHERWOOD
Regulation Number878.3680
Classification Product Code
FZE  
Date Received09/24/1990
Decision Date 11/26/1990
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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