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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 K884250
Device Name RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact BYRON WICKETT
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact BYRON WICKETT
Classification Product Code
LCJ  
Date Received10/11/1988
Decision Date 06/12/1989
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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