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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phantom, Anthropomorphic, Nuclear
510(k) Number K844189
Device Name LINEAR SCANNER PROBE ELSCINT LTD. TL-35
Applicant
Elscint, Inc.
775 Nicholas Blvd.
Elk Grove Village,  IL  60007
Applicant Contact ROBERT E KENNEY
Correspondent
Elscint, Inc.
775 Nicholas Blvd.
Elk Grove Village,  IL  60007
Correspondent Contact ROBERT E KENNEY
Regulation Number892.1370
Classification Product Code
IYP  
Date Received10/30/1984
Decision Date 02/25/1985
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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