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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 K896324
Device Name ELITE 1500 RADIOGRAPHIC TILTING TABLE
Applicant
Rms Div.
2301 Windsor Ct.
Addison,  IL  60101
Applicant Contact WILLIAM J ENGEL
Correspondent
Rms Div.
2301 Windsor Ct.
Addison,  IL  60101
Correspondent Contact WILLIAM J ENGEL
Regulation Number892.1980
Classification Product Code
IXR  
Date Received11/01/1989
Decision Date 11/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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