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510(k) K921355

Device
WINGMASTER
Applicant
INNOVATORS, INC.
510(k) number
K921355
Product code
EHB  
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-25
Date received
1992-03-20
Regulation
872.1840
Classification name
Collimator, X-ray
Medical specialty
Dental
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DON GENTRY
Address
2721 D Industrial Dr. Jefferson City MO US 65109 65109

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EHB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K903012AUDIOPRAT ENDOSCOPES.C.D.P.I. of Florida, Inc.1990-10-09
K834606X-RAY COLLIMATOR X-CJDKnochen Dental Laboratory1984-02-21
K833558X-RAY SHIELDMoyco Industries, Inc.1984-01-13
K781675X-RAY COLLIMATORGeneral X-Ray, Inc.1978-12-04

Legacy Summary#

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FDA Review#

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