NATRELLE INSPIRA Single Use Sizers For Gel Implants

Sizer, Mammary, Breast Implant Volume

Allergan

The following data is part of a premarket notification filed by Allergan with the FDA for Natrelle Inspira Single Use Sizers For Gel Implants.

Pre-market Notification Details

Device IDK203229
510k NumberK203229
Device Name:NATRELLE INSPIRA Single Use Sizers For Gel Implants
ClassificationSizer, Mammary, Breast Implant Volume
Applicant Allergan 2525 Dupont Dr. Irvine,  CA  92612
ContactKelly Carty
CorrespondentKelly Carty
Allergan 2525 Dupont Dr. Irvine,  CA  92612
Product CodeMRD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-02
Decision Date2021-06-02

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