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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 K926056
Device Name 9600 FLUOROSCOPIC IMAGING SYSTEM
Applicant
Oec-Diasonics, Inc.
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact THOMAS R MEYERS
Correspondent
Oec-Diasonics, Inc.
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Correspondent Contact THOMAS R MEYERS
Regulation Number892.1650
Classification Product Code
OXO  
Date Received12/01/1992
Decision Date 01/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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