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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 K901012
Device Name RADIOGRAPHIC GRID
Applicant
Infab Corp.
3651 Via Pescador
Camarillo,  CA  93012
Applicant Contact DON CUSICK
Correspondent
Infab Corp.
3651 Via Pescador
Camarillo,  CA  93012
Correspondent Contact DON CUSICK
Regulation Number892.1910
Classification Product Code
IXJ  
Date Received03/05/1990
Decision Date 03/28/1990
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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