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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K910092
Device Name 3M LASER IMAGER XL
Applicant
3M Medical Products Group
3m Center, Bldg. 275-3e-08
St Paul,  MN  55144
Applicant Contact GRAVELLE
Correspondent
3M Medical Products Group
3m Center, Bldg. 275-3e-08
St Paul,  MN  55144
Correspondent Contact GRAVELLE
Regulation Number892.2040
Classification Product Code
LMC  
Date Received01/09/1991
Decision Date 04/08/1991
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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