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510(k) K913772

Device
PRESSURE GUARD
Applicant
BEACON LABORATORIES, INC.
510(k) number
K913772
Product code
LCJ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-11-19
Date received
1991-08-23
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
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD P FLEENOR
Address
2150 W. 6th Ave., Unit P Broomfield CO US 80020 80020

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#

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FDA Review#

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