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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Manual, Radiographic
510(k) Number K900007
Device Name R-100-ET MANUAL COLLIMATOR
Applicant
Advantech
16 Lawrence St.
Wakefield,  MA  01880
Applicant Contact CHARLES E MORELAND
Correspondent
Advantech
16 Lawrence St.
Wakefield,  MA  01880
Correspondent Contact CHARLES E MORELAND
Regulation Number892.1610
Classification Product Code
IZX  
Date Received01/02/1990
Decision Date 02/06/1990
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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