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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Automatic, Radiographic
510(k) Number K911127
Device Name COLLIMASTER-90
Applicant
Varian Assoc., Inc.
301 Industrial Way
San Carlos,  CA  94070
Applicant Contact LINDA LARSEN
Correspondent
Varian Assoc., Inc.
301 Industrial Way
San Carlos,  CA  94070
Correspondent Contact LINDA LARSEN
Regulation Number892.1610
Classification Product Code
IZW  
Date Received03/14/1991
Decision Date 09/19/1991
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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