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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K843165
Device Name ULTRASOUND 72X & ANNULAR ARRAY SCAN-
Applicant
Advanced Technology Laboratories, Inc.
P.O. Box 6639
Bellevue,  WA  98008
Applicant Contact FRANCIS G MSITH
Correspondent
Advanced Technology Laboratories, Inc.
P.O. Box 6639
Bellevue,  WA  98008
Correspondent Contact FRANCIS G MSITH
Regulation Number870.2880
Classification Product Code
JOP  
Date Received08/13/1984
Decision Date 12/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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