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510(k) K934459

Device
MED-GENESIS PATIENT LASER EYE SHIELD
Applicant
MED-GENESIS, INC.
510(k) number
K934459
Product code
IWS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-22
Date received
1993-09-10
Regulation
892.6500
Classification name
Shield, Eye, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CAROLANN KOTULA-COOK
Address
55 Northern Blvd., Suite 410 Great Neck, NY US 11021 11021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945515COATED TUNGSTEN EYESHIELDMedtec, Inc.1995-06-19
K940119ROYAL MARSDEN GOLD GRAIN GUNBest Industries1994-12-30
K943011TUNGSTEN EYESHIELDMedtec, Inc.1994-12-23
K934362NUCLEAR ASSOCIATES GLASSERSVictoreen, Inc.1993-11-12
K920540RADIOLOGICAL PROTECTIVE EYE SHIELDBurkhart Roentgen Intl., Inc.1992-05-28

Legacy Summary#

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FDA Review#

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