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510(k) K161176

ARTOURA Breast Tissue Expanders with Smooth Surface by Mentor Worldwide, LLC — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2016
Date Received
April 26, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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