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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 K883303
Device Name MENTOR RAPID-SPAN (TM) TISSUE EXPANDER
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact BYRON WICKET
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact BYRON WICKET
Regulation Number878.4800
Classification Product Code
FZW  
Date Received08/04/1988
Decision Date 08/26/1988
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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