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510(k) K203229

Device
NATRELLE INSPIRA Single Use Sizers For Gel Implants
Applicant
Allergan
510(k) number
K203229
Product code
MRD  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-02
Date received
2020-11-02
Regulation
510(k) Premarket Notification
Classification name
Sizer, Mammary, Breast Implant Volume
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kelly Carty
Address
2525 Dupont Dr. Irvine CA US 92612 92612

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC2025-01-13
K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC2024-09-06
K200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.2020-11-16
K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC2019-02-05
K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMentor Worldwide, LLC2015-05-20
K131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMentor Worldwide, LLC2013-07-17
K062421MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMentor Corporation2006-10-10
K010709MENTOR STERILE SALINE MAMMARY VOLUME SIZERSMentor Corp.2001-04-23
K984106MAMMARY SIZER, MAMMARY PROTHESIS SIZERSpecialty Surgical Products, Inc.1999-02-12
K982258MAMMARY SIZERSpecialty Surgical Products, Inc.1998-09-08
K961356MAMMARY SIZERGeneral Surgical Innovations1996-09-23
K831566CUI MAMMARY PROTHESIS SIZERCox-Uphuff Intl.1983-08-12

Legacy Summary#

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FDA Review#

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