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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Illuminator, Radiographic-Film
510(k) Number K875233
Device Name VARIVIEWER (X-RAY FILM VIEWER)
Applicant
Diversified Diagnostic Products, Inc.
11603 Windfern
Houston,  TX  77064
Applicant Contact GERALD TIMPE
Correspondent
Diversified Diagnostic Products, Inc.
11603 Windfern
Houston,  TX  77064
Correspondent Contact GERALD TIMPE
Regulation Number892.1890
Classification Product Code
IXC  
Date Received12/22/1987
Decision Date 01/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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