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510(k) K940119

Device
ROYAL MARSDEN GOLD GRAIN GUN
Applicant
BEST INDUSTRIES
510(k) number
K940119
Product code
IWS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-30
Date received
1994-01-10
Regulation
892.6500
Classification name
Shield, Eye, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SANKARA I RAMASWAMY
Address
7643 Fullerton Rd. Springfield VA US 22153 22153

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IWS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945515COATED TUNGSTEN EYESHIELDMedtec, Inc.1995-06-19
K943011TUNGSTEN EYESHIELDMedtec, Inc.1994-12-23
K934459MED-GENESIS PATIENT LASER EYE SHIELDMed-Genesis, Inc.1994-02-22
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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