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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 K810598
Device Name X-RAY COLLIMATING DEVICES
Applicant
Midmark Corp.
60 Vista Dr.
Versailles,  OH  45380
Applicant Contact SCOTT GORE
Correspondent
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Correspondent Contact John T Davidson
Regulation Number892.1610
Classification Product Code
IZW  
Subsequent Product Code
IZX  
Date Received03/06/1981
Decision Date 04/10/1981
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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