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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K010942
Device Name U04
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact AMY SHAW HOSLER
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received03/29/2001
Decision Date 04/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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