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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 K930635
Device Name MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number892.1600
Classification Product Code
IZI  
Date Received02/08/1993
Decision Date 09/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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