FDA.reportPublic FDA data

510(k) K845036

Device
TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600
Applicant
PROGRESS MANKIND TECHNOLOGY
510(k) number
K845036
Product code
LCJ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-26
Date received
1984-12-27
Regulation
510(k) Premarket Notification
Classification name
Expander, Skin, Inflatable
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
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALFRED A IVERSEN
Address
Box 464 Hopkins MN US 55343 55343

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254126Natrelle 133S Tissue ExpandersAbbVie2026-01-16
K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLC2025-04-24
K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC2025-01-12
K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC2024-08-02
K211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC2023-10-13
K214124AlloX2 Pro Tissue ExpandersSientra, Inc.2023-06-08
K221127Sientra, inc. PortfinderSientra, Inc.2023-05-10
K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan2018-12-21
K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC2018-09-25
K182054Natrelle 133S Tissue ExpanderAllergan2018-08-29
K161483Unger Quad InjectorStradis Healthcare2016-10-31
K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC2016-05-23
K152496CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC2016-02-19
K143354Natrelle 133 Plus Tissue ExpanderAllergan, Inc.2015-08-20
K150777Artoura Breast Tissue ExpanderMentor Worldwide, LLC2015-04-24

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases