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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 K102806
Device Name NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS
Applicant
Allergan Medical
71 S. Los Carneros Rd.
Goleta,  CA  93117
Applicant Contact MICAH SCHLOSS
Correspondent
Allergan Medical
71 S. Los Carneros Rd.
Goleta,  CA  93117
Correspondent Contact MICAH SCHLOSS
Classification Product Code
LCJ  
Date Received09/28/2010
Decision Date 01/05/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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