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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 K844813
Device Name MENTOR EXPANDER MAMMARY PROSTHESIS
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact CHRISTINE EMANUEL
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact CHRISTINE EMANUEL
Classification Product Code
LCJ  
Date Received12/11/1984
Decision Date 05/10/1985
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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