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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K962750
Device Name 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
Applicant
Imation Corp.
1 Imation Pl.
Oakdale,  MN  55128
Applicant Contact STEPHEN G SLAVENS
Correspondent
Imation Corp.
1 Imation Pl.
Oakdale,  MN  55128
Correspondent Contact STEPHEN G SLAVENS
Regulation Number892.1900
Classification Product Code
IXW  
Date Received07/15/1996
Decision Date 08/21/1996
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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