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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 K853945
Device Name CUI RHINOPLASTY IMPLANTS
Applicant
Cox-Uphuff Intl.
725 E. Yanonali St.
Santa Barbara,  CA  93103
Applicant Contact DAVID J SCHUESSLER
Correspondent
Cox-Uphuff Intl.
725 E. Yanonali St.
Santa Barbara,  CA  93103
Correspondent Contact DAVID J SCHUESSLER
Regulation Number878.3680
Classification Product Code
FZE  
Date Received09/24/1985
Decision Date 10/18/1985
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
Predetermined Change
Control Plan Authorized		 No
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