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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 K844247
Device Name ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS
Applicant
Technicare Corp.
90 Inverness Circle E.
Englewood,  CO  80112
Applicant Contact DAVID A ENSOR
Correspondent
Technicare Corp.
90 Inverness Circle E.
Englewood,  CO  80112
Correspondent Contact DAVID A ENSOR
Regulation Number882.1925
Classification Product Code
GXX  
Date Received11/01/1984
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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