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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 K862049
Device Name MENTOR FLAT-SPAN
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact KAREN EDWARDS
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact KAREN EDWARDS
Classification Product Code
LCJ  
Date Received05/29/1986
Decision Date 06/10/1986
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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