FDA.reportPublic FDA data

510(k) K934549

Device
ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
Applicant
VICTOREEN, INC.
510(k) number
K934549
Product code
IWR  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-19
Date received
1993-09-22
Regulation
892.6500
Classification name
Holder, Syringe, Lead
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CHRISTINE L JESS
Address
6000 Cochran Rd. Cleveland OH US 44130 44130

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
K872656LEAD GLASS SHIELDSViox Corp.1987-07-16
K863936DUFFY BOLUS INJECTORViox Corp.1987-01-06
K811688TUNGSTEN SYRINGE SHIELDMedi-Physics Inc. Dba Nycomed Amersham Imaging1981-07-02

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases