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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 K980722
Device Name TRIMAX RADIOGRAPHIC CASSETTE
Applicant
Imation Corp.
1 Imation Place
Oakdale,  MN  55128
Applicant Contact STEPHEN G SLAVENS
Correspondent
Imation Corp.
1 Imation Place
Oakdale,  MN  55128
Correspondent Contact STEPHEN G SLAVENS
Regulation Number892.1850
Classification Product Code
IXA  
Date Received02/24/1998
Decision Date 03/23/1998
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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