FDA.reportPublic FDA data

510(k) K050851

Device
DELTA PUNCTUM PLUG
Applicant
DELTA LIFE SCIENCE, INC.
510(k) number
K050851
Product code
LZU  
Decision
Substantially Equivalent (SESE)
Decision date
2005-08-19
Date received
2005-04-04
Regulation
510(k) Premarket Notification
Classification name
Plug, Punctum
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
Ophthalmic
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GEORGE W MURRAY
Address
1975 Nonconnah Blvd. Memphis TN US 38132 38132

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LZU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241229Hello,eyes® BIO PlugBio Optics Co., Ltd.2024-06-28
K222164Visant Medical Canalicular PlugVisant Medical, Inc.2022-12-23
K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc.2022-06-03
K190210Tear Pool Dissolvable Punctum PlugsAlphamed, Inc.2019-10-24
K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc.2017-04-17
K161673LacriPro Punctum PlugLacrimedics, Inc.2016-11-18
K150288PDO Absorbable Punctum PlugRiverpoint Medical2015-08-28
K140352VERAPLUGKrishna Imports Inc Dba Stephens Instruments2014-11-13
K140711COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,Paragon Bioteck, Inc.2014-06-20
K140026COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TESTLacrimedics, Inc.2014-06-03
K090938FLOW CONTROLLEROdyssey Medical, Inc.2009-06-04
K061398SNUG PLUG PUNCTUM PLUGFci Ophthalmics, Inc.2006-07-11
K053333EAGLEVISION GELLANSERTS, MODEL REF 0040Eagle Vision, Inc.2006-05-02
K040912HYDROGEL CANALICULAR PLUGPartners IN Biomaterials, Inc.2004-11-16
K040231INTELIPORT OCCLUDING DEVICEAlcon, Inc.2004-07-13

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