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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 K143354
Device Name Natrelle 133 Plus Tissue Expander
Applicant
Allergan, Inc.
2525 Dupont Dr.
Irvine,  CA  92623 -9534
Applicant Contact Bruce Krattenmaker
Correspondent
Allergan, Inc.
2525 Dupont Dr.
Irvine,  CA  92623 -9534
Correspondent Contact Bruce Krattenmaker
Classification Product Code
LCJ  
Date Received11/24/2014
Decision Date 08/20/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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