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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, Diagnostic
510(k) Number K912361
Device Name SI-450/ILUS (INTRALUMINAL ULTRASOUND)
Applicant
Siemens Ultrasound, Inc.
2527 Camino Ramon, Suite 100
San Ramon,  CA  94583
Applicant Contact RICHARD JANOSKO
Correspondent
Siemens Ultrasound, Inc.
2527 Camino Ramon, Suite 100
San Ramon,  CA  94583
Correspondent Contact RICHARD JANOSKO
Regulation Number892.1570
Classification Product Code
ITX  
Date Received05/29/1991
Decision Date 12/02/1991
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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