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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name image-intensified fluoroscopic x-ray system, mobile
510(k) Number K900967
Device Name MODIFIED ALPHA MC-9R C-ARM
Applicant
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207 -6025
Applicant Contact GERRY L BUSS
Correspondent
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207 -6025
Correspondent Contact GERRY L BUSS
Regulation Number892.1650
Classification Product Code
OXO  
Date Received03/02/1990
Decision Date 05/09/1990
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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