FDA.reportPublic FDA data

510(k) K994289

Device
SUTUREGROOVE
Applicant
IOP, INC.
510(k) number
K994289
Product code
MML  
Decision
Substantially Equivalent (SESE)
Decision date
2000-04-17
Date received
1999-12-21
Regulation
886.5700
Classification name
Weights, Eyelid, External
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JASON MALECKA
Address
3151 Airway Ave., Bldg. I-1 Costa Mesa CA US 92626 92626

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MML  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170591Altomed Malhotra Platinum SegmentsAltomed Limited2017-06-06
K150986Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation2015-08-17
K021750LID CHAIN EYELID WEIGHTSJedmed Instrument Co.2003-01-27
K011740CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)Meddev Corp.2001-07-02
K011115KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010Heinz Kurz GmbH Medizintechnik2001-05-02
K003646SUTUREGROOVE WEIGHT SIZING SETIop, Inc.2001-02-22
K001123KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111Heinz Kurz GmbH Medizintechnik2000-04-21
K000127KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10Heinz Kurz GmbH Medizintechnik2000-04-12
K990224LABTICIAN LID LOAD EXTERNAL EYELID SIZING SETLabtician Ophthalmics, Inc.1999-04-12
K983607LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTSLabtician Ophthalmics, Inc.1999-01-08
K971242BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)Ipax, Inc.1997-12-17
K971245BLINK EXTERNAL EYELID WEIGHTIpax, Inc.1997-06-20
K940974EYECLOSE EXTERNAL EYELID WEIGHTSMeddev Corp.1994-06-08

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