FDA.reportPublic FDA data

510(k) K022842

Device
STEPHENS DISPOSABLE HOOKS
Applicant
Stephens Instruments
510(k) number
K022842
Product code
HNQ
Decision
Substantially Equivalent (SESE)
Decision date
2002-11-01
Date received
2002-08-27
Regulation
886.4350
Classification name
Hook, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ARCHALA 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 HNQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K030471OPHTEC ENCLAVATION NEEDLEOphtec, USA2003-04-17
K874991PRISMA DISPOSABLE IRRIGATING IRIS HOOKAdvanced Surgical Products, Inc.1988-04-13
K870440LOOK LENS LOOPSLook, Inc.1987-02-20
K864292DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGYEye-Ko, Inc.1986-12-29
K863988THORTON TITANIUM HOOK ANGLED RIGHTKeeler Instruments, Inc.1986-10-31
K801469BONN MICRO IRIS HOOK (NON-STERILE) #7613Edward Weck, Inc.1980-07-28
K791985HOOKS #'S 7600,7602,7603,7616Edward Weck, Inc.1979-10-04
K770103HOOK, IRIS, SHEPARD U-SHAPEDEdward Weck, Inc.1977-01-25
K770098HOOK, IRIS, HERSHMANEdward Weck, Inc.1977-01-24