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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K192196
Device Name Medical Radiation Dosimetry System microSTARii
Applicant
Landauer
2 Science Rd.
Glenwood,  IL  60425
Applicant Contact Matt Ennis
Correspondent
Landauer
2 Science Rd.
Glenwood,  IL  60425
Correspondent Contact Matt Ennis
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/13/2019
Decision Date 12/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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