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510(k) K811688

Device
TUNGSTEN SYRINGE SHIELD
Applicant
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING
510(k) number
K811688
Product code
IWR  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-02
Date received
1981-06-15
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K872656LEAD GLASS SHIELDSViox Corp.1987-07-16
K863936DUFFY BOLUS INJECTORViox Corp.1987-01-06

Legacy Summary#

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FDA Review#

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