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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K971431
Device Name UMI X-RAY FILM CASSETTE
Applicant
Umi Intl.
18 Roberts Dr.
Bedford,  MA  01730
Applicant Contact KWANG CHAE JUNG
Correspondent
Umi Intl.
18 Roberts Dr.
Bedford,  MA  01730
Correspondent Contact KWANG CHAE JUNG
Regulation Number892.1850
Classification Product Code
IXA  
Date Received04/17/1997
Decision Date 05/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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