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510(k) K972229

IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM by Heartware, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1997
Date Received
June 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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