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510(k) K844716

Device
MAGNIFYING SPECTACLES W/PLASTIC LENSES
Applicant
GAZELLE CORP.
510(k) number
K844716
Product code
HOI  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-03
Date received
1984-12-04
Regulation
886.5840
Classification name
Spectacle, Magnifying
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL HUANG
Address
72-9 Jen Ai Rd., Sec. 2 Taipei TW

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HOI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943613NILSing Wah International Enterprises , Ltd.1994-09-21
K930435SPECTACLE FRAMESVenis DI A. Vendrame1993-09-20
K931328PYRAMID SUNGLASSES/PYRAMID READING GLASSESPyramid1993-08-10
K910329SUNGLASSESCutler & Gross Sloan Optical , Ltd.1991-03-12
K854854SYSTEMS OF SIGHT LOW VISION EYEWAREInt'L Eye Care, Inc.1986-02-04
K844038VISITEC MAGNIFYING SPECTACLESVisitec Co.1984-11-29
K842835BRILLETTE MODELCillus Company, Inc.1984-11-21
K820732LA VEL LATERAL VIEW EXTENSION LENSPeter M. Tolliver1982-05-03
K813548UVEX MINI-SPECSBacou USA, Inc. and Uvex Safety, Inc.1982-03-02
K801733FENZL RETICLERobert E. Fenzl, M.D.1980-09-16

Legacy Summary#

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FDA Review#

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