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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Expander And Accessories
510(k) Number K865033
Device Name BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER
Applicant
Cox-Uphuff Intl.
1160 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact DAVID J SCHUESSLER
Correspondent
Cox-Uphuff Intl.
1160 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact DAVID J SCHUESSLER
Classification Product Code
LCJ  
Date Received12/23/1986
Decision Date 01/12/1987
Decision Substantially Equivalent (SESE)
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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