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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Test, Ultrasonic Scanner Calibration
510(k) Number K844120
Device Name ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
Applicant
Echo Ultrasound
Post Office Box 552
Lewistown,  PA  17044
Applicant Contact RUSSELL W WOODS
Correspondent
Echo Ultrasound
Post Office Box 552
Lewistown,  PA  17044
Correspondent Contact RUSSELL W WOODS
Regulation Number882.1925
Classification Product Code
GXX  
Date Received10/23/1984
Decision Date 01/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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