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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 K890636
Device Name CARDIAC COMPUTATION SOFTWARE PACKAGE
Applicant
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Applicant Contact M SOBEL,ESQ
Correspondent
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Correspondent Contact M SOBEL,ESQ
Regulation Number870.2880
Classification Product Code
JOP  
Date Received02/08/1989
Decision Date 08/07/1989
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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