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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, Stationary Top
510(k) Number K873849
Device Name ALTAIREX BUCKY/CASSETTE TRAY COMBINATION
Applicant
Altairex Manufacturing, Inc.
1252 Chinook Way
Boulder,  CO  80303
Applicant Contact ALDONA A SICZEK,PHD
Correspondent
Altairex Manufacturing, Inc.
1252 Chinook Way
Boulder,  CO  80303
Correspondent Contact ALDONA A SICZEK,PHD
Regulation Number892.1980
Classification Product Code
IXQ  
Date Received09/22/1987
Decision Date 10/28/1987
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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