FDA.reportPublic FDA data

510(k) K944445

Device
Ed Corp Radiation Screen
Applicant
MED CORP.
510(k) number
K944445
Product code
EAK
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-11
Date received
1994-09-12
Regulation
892.6500
Classification name
Screen, Leaded, Operator Radiation Protector
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM R TOUT
Address
101 N. Dayon P.O. Box 50010 Ames IA US 50010 50010

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EAK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952233CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628Victoreen, Inc.1995-06-16
K944772MULTIPLE ED1600 SERIES RADIATION SHIELDSImage Diagnostics, Inc.1994-10-20
K896949MOBILE X-RAY PERSONNEL PROTECTIVE SCREENSInnovative Products Mfg.1990-02-16
K861019CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELDPhase One Disign Co.1986-04-02
K850814MODULAR X-RAY BARRIERSVictoreen, Inc.1985-04-10
K850816LEAD PLASTIC VIEWING PANELSVictoreen, Inc.1985-04-10