FDA.reportPublic FDA data

510(k) K830430

Device
Eyelid Speculum
Applicant
DOUGLAS C. MCKEE & CO.
510(k) number
K830430
Product code
HNC
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-10
Date received
1983-02-09
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K863989THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)Keeler Instruments, Inc.1986-10-31
K863664OPHTHALMIC SURGICAL SPECULUMMyocure, Inc.1986-09-25
K843196VISITEC EYE SPECULUMVisitec Co.1984-10-05
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