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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Expander, Surgical, Skin Graft
510(k) Number K904265
Device Name INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER
Applicant
Inamed Development Co.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Applicant Contact ELLEN DUKE
Correspondent
Inamed Development Co.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Correspondent Contact ELLEN DUKE
Regulation Number878.4800
Classification Product Code
FZW  
Date Received09/18/1990
Decision Date 03/06/1991
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
Predetermined Change
Control Plan Authorized		 No
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