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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 K970734
Device Name SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Applicant Contact JING ZHANG
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Correspondent Contact JING ZHANG
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received02/28/1997
Decision Date 04/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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