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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K151302
Device Name Clinpro Varnish
Applicant
3m Company
2510 Conway Avenue
St. Paul,  MN  55144 -1000
Applicant Contact Shari L. Myszka
Correspondent
3m Company
2510 Conway Avenue
St. Paul,  MN  55144 -1000
Correspondent Contact Shari L. Myszka
Regulation Number872.3260
Classification Product Code
LBH  
Date Received05/15/2015
Decision Date 09/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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