FDA.reportPublic FDA data

510(k) K022835

Device
STEPHENS DISPOSABLE FORCEPS
Applicant
Stephens Instruments
510(k) number
K022835
Product code
HNR
Decision
Substantially Equivalent (SESE)
Decision date
2002-11-01
Date received
2002-08-27
Regulation
886.4350
Classification name
Forceps, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ARCHANA JOHNSON
Address
2500 Sandersville Rd. Lexington KY US 40511 40511

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HNR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K895434ALCON FOLDING FORCEPSAlcon Laboratories1989-12-04
K891487SOFT LENS FOLDING BLOCKWestern Medical Products, Inc.1989-08-15
K893199PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTRAllergan Medical Optics1989-06-16
K885230MCDONALD FOLDING FORCEPSAlcon Laboratories1989-05-17
K881049BRADBURY INTRAOCULAR RETINAL KIT CAT #200Microline Pentax, Inc.1988-09-12
K883197IOL IMPLANTATION FORCEPSD & D Surgical1988-08-22
K880274ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPSAdvanced Surgical Products, Inc.1988-02-05
K864266OPHTHALMIC KNIFE & FORCEPSWestern Medical Products, Inc.1986-11-28
K864183OPHTHALMIC SURGICAL INSTRUMENTSTechno Ophthalmics Intl.1986-11-28
K864071FAULKNER FORCEPSStaar Surgical Co.1986-11-13
K863992THORNTON TITANIUM FORCEPS (VARIOUS TYPES)Keeler Instruments, Inc.1986-10-31
K863727FIXATION INSTRUMENTSMedical Technology Development Corp.1986-10-31
K863991THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STANDKeeler Instruments, Inc.1986-10-31
K864003PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPSAllergan, Inc.1986-10-31
K861141MANUAL OPHTHALMIC SURGICAL INSTRUMENTSCooperVision, Inc.1986-04-24