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510(k) K872656

Device
LEAD GLASS SHIELDS
Applicant
VIOX CORP.
510(k) number
K872656
Product code
IWR  
Decision
Substantially Equivalent (SESE)
Decision date
1987-07-16
Date received
1987-07-07
Regulation
892.6500
Classification name
Holder, Syringe, Lead
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
THOMAS W BURNETT
Address
6701 Sixth Ave. S. Seattle WA US 98108 98108

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934549ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELDVictoreen, Inc.1994-02-19
K863936DUFFY BOLUS INJECTORViox Corp.1987-01-06
K811688TUNGSTEN SYRINGE SHIELDMedi-Physics Inc. Dba Nycomed Amersham Imaging1981-07-02

Legacy Summary#

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FDA Review#

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