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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 K912225
Device Name 3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT
Applicant
3M Medical Products Group
3m Center, Bldg. 275-3e-08
St Paul,  MN  55144
Applicant Contact JOHN GRAVELLE
Correspondent
3M Medical Products Group
3m Center, Bldg. 275-3e-08
St Paul,  MN  55144
Correspondent Contact JOHN GRAVELLE
Regulation Number892.1900
Classification Product Code
IXW  
Date Received05/20/1991
Decision Date 07/22/1991
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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