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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, tooth shade, resin
510(k) Number K991961
Device Name 3M LVR SYSTEM
Applicant
3M COMPANY
3M CENTER
BLDG. 275-3SE-08
st. paul,  MN  55144 -1000
Applicant Contact lael j pickett
Correspondent
3M COMPANY
3M CENTER
BLDG. 275-3SE-08
st. paul,  MN  55144 -1000
Correspondent Contact lael j pickett
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/10/1999
Decision Date 08/09/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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