FDA.reportPublic FDA data

510(k) K863989

Device
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
Applicant
KEELER INSTRUMENTS, INC.
510(k) number
K863989
Product code
HNC  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-31
Date received
1986-10-14
Regulation
886.4350
Classification name
Specula, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
VAN ARSDALE
Address
456 Pkwy. Broomall PA US 19008 19008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022836STEPHENS DISPOSABLE SPECULUMStephens Instruments2002-11-01
K981235OCULOSTATLaser Center Dev. Corp.1998-07-15
K964289EYE FIXATION SPECULUMEyefix, Inc.1996-12-17
K863664OPHTHALMIC SURGICAL SPECULUMMyocure, Inc.1986-09-25
K843196VISITEC EYE SPECULUMVisitec Co.1984-10-05
K830430EYELID SPECULUMDouglas C. Mckee & Co.1983-06-10
K801969ASNIS GUIDED SCREW SYSTEMSHowmedica Corp.1980-08-27
K760847FELDSTEIN BLEPHAROPLASTY CLIP SHARP PV. Mueller O.V. Baxter Healthcare Corp.1976-11-02
K760848FELDSTEIN BLEPHAROPLASTY CLIP RECTANGUV. Mueller O.V. Baxter Healthcare Corp.1976-11-02
K760849FELDSTEIN BLEPHAROSTOMY CLIP SQUAREV. Mueller O.V. Baxter Healthcare Corp.1976-11-02

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