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510(k) K030471

Device
OPHTEC ENCLAVATION NEEDLE
Applicant
OPHTEC USA
510(k) number
K030471
Product code
HNQ  
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-17
Date received
2003-02-12
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
No

Applicant Contact#

Contact
RICK MCCARLEY
Address
6421 Congress Ave., Suite 112 Boca Raton FL US 33487 33487

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
K022842STEPHENS DISPOSABLE HOOKSStephens Instruments2002-11-01
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

Legacy Summary#

summary

FDA Review#

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