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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K973303
Device Name IMATION MODEL 9410 NETWORK INTERFACE
Applicant
Imation Corp.
3m Center, 235-2b-23
St. Paul,  MN  55144 -1000
Applicant Contact STEPHEN G SLAVENS
Correspondent
Imation Corp.
3m Center, 235-2b-23
St. Paul,  MN  55144 -1000
Correspondent Contact STEPHEN G SLAVENS
Regulation Number892.2020
Classification Product Code
LMD  
Date Received09/03/1997
Decision Date 11/25/1997
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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