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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K933073
Device Name HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE
Applicant
Heartware Intl. Corp.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA SINCLAIR
Correspondent
Heartware Intl. Corp.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA SINCLAIR
Regulation Number892.1600
Classification Product Code
IZI  
Date Received06/23/1993
Decision Date 10/07/1993
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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