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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test-Pattern, Radiographic
510(k) Number K834482
Device Name TISSUE MIMICKING ULTRASOUND PHANTOMS
Applicant
Radiation Measurements, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Radiation Measurements, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1940
Classification Product Code
IXF  
Date Received12/15/1983
Decision Date 01/25/1984
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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