FDA.reportPublic FDA data

510(k) K970318

Device
OCULAR CONFORMER
Applicant
SOUTHWEST ARTIFICIAL EYES, INC.
510(k) number
K970318
Product code
HQN  
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-07
Date received
1997-01-28
Regulation
886.3130
Classification name
Conformer, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DANIEL M WENSKE
Address
4640 Centerview San Antonio TX US 78228 78228

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HQN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972034MEDPOR OCULAR CONFORMERPorex Surgical, Inc.1998-01-20
K970319OCULAR CONFORMERXavier A. Guerra, Ocularist, Inc.1997-07-07
K945110KOLBERG OPHTHALMIC CONFORMERKolberg Ocular Products, Inc.1995-01-13
K921221STERILE/SINGLE USE SYMBLEPHARON RINGStorz Instrument Co.1992-07-17
K921229STERILE/SINGLE USE OPHTHALMIC CONFORMERSStorz Instrument Co.1992-06-09
K772168MOLDEYERobert B. Scott Ocularists of Florida, Inc.1977-11-30

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