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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Grid, Radiographic
510(k) Number K962338
Device Name RADIOGRAPHIC GRID
Applicant
Unidex Group, Inc.
2400 E. Devon Ave.
Des Plaines,  IL  60018
Applicant Contact HENRY LEE
Correspondent
Unidex Group, Inc.
2400 E. Devon Ave.
Des Plaines,  IL  60018
Correspondent Contact HENRY LEE
Regulation Number892.1910
Classification Product Code
IXJ  
Date Received06/17/1996
Decision Date 07/03/1996
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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