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510(k) K973526

Device
SUNGLASSES
Applicant
PYRAMID HANDBAGS, INC.
510(k) number
K973526
Product code
HQY  
Decision
Substantially Equivalent (SESE)
Decision date
1997-10-16
Date received
1997-09-18
Regulation
886.5850
Classification name
Sunglasses (non-prescription Including Photosensitive)
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JENNIFER EPSTEIN
Address
100 W. 33rd St., Suite 800 New York NY US 10001 10001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HQY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.1998-01-30
K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.1998-01-30
K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.1998-01-27
K974511SUNGLASSESSun World Intl., Inc.1998-01-12
K974441SUNGLASSESHip Shing Fat Co., Ltd.1998-01-09
K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.1997-12-08
K974414MULTIMorning Calm Corp.1997-12-08
K974179NON-PRESCRIPTION SUNGLASSESTaipan Optical Company , Ltd.1997-12-01
K974045VENNETOAmsure Sports, Inc.1997-11-20
K973934SUNGLASSESElegance Optical Manufactory, Ltd.1997-11-18
K973407SUNGLASSES (NON-PRESCRIPTION)Pacific Optical Co. , Ltd.1997-09-30
K973490SUNGLASSESTong Yang Optical Co.1997-09-30
K972850SUNGLASSESIndoptica, S.A.1997-09-17
K973016NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASSOptimaxx Intl.1997-09-17
K972717RUFF WORK EYEGEARRuff House, Inc.1997-08-25

Legacy Summary#

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FDA Review#

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