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510(k) K945450

Device
FRAME, SPECTACLE
Applicant
KOOKJE APIS INDUSTRIAL CO.
510(k) number
K945450
Product code
HQZ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-22
Date received
1994-11-03
Regulation
886.5842
Classification name
Frame, Spectacle
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HAETONG SOHN
Address
Rm. 600 120-13 Sosomoontong Choong-Ku Seoul KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HQZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952597VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEWPoint of View Optical Outlet, Inc.1995-09-12
K944313SPECTACLE FRAMESun Hing Optical Manufactory , Ltd.1995-03-28
K945176SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.1994-12-15
K945392SPECTACLE FRAMESeo Han Corp., Ltd.1994-12-15
K945770OPTICAL FRAMESRamada Optics, Inc.1994-12-15
K945350FRAME, SPECTACLESTaiwan Eva Industrial Co., Inc.1994-12-13
K945342MAG-1 SPECTACLE FRAMECriss Optical Mfg. Co., Inc.1994-11-28
K945123ARISTAR EYEWEAR, ESPRIT EYEWEARAristar Inc. U.S.A.1994-11-22
K945323SPECTACLE FRAMEM.Y. Vision Corp.1994-11-22
K945340SPECTACLE FRAMES OR EYEGLASS FRAMESMi Mun Corp.1994-11-22
K944641NILMax-Vision (H.K.)Limited1994-11-14
K944160SILHOUETTE, SUNLIMETED,ADIDASSilhouette Optical , Ltd.1994-09-28
K944373SPECTACLE FRAMESCustom Optical Frames, Inc.1994-09-28
K943561SPECTACLE FRAMEAustralian Optical Co., Inc.1994-09-14
K943641SPECTACLE FRAMEAustralian Optical Co., Inc.1994-09-14

Legacy Summary#

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FDA Review#

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