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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K033604
Device Name TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
Applicant
Pie Medical
7992 Castleway Dr.
Indianpolis,  IN  46250
Applicant Contact COLLEEN DENSMORE
Correspondent
Pie Medical
7992 Castleway Dr.
Indianpolis,  IN  46250
Correspondent Contact COLLEEN DENSMORE
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received11/17/2003
Decision Date 12/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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