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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Tilting
510(k) Number K965096
Device Name FLUOROVIEW SERIES FLUOROSCOPIC TABLES
Applicant
U.S. Imaging Tables, Inc.
28 Central Ave.
Happauge,  NY  11788
Applicant Contact ROBALD DENEZZO
Correspondent
U.S. Imaging Tables, Inc.
28 Central Ave.
Happauge,  NY  11788
Correspondent Contact ROBALD DENEZZO
Regulation Number892.1980
Classification Product Code
IXR  
Date Received12/20/1996
Decision Date 01/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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