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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K020394
Device Name APC PLUS ADHESIVE
Applicant
3M UNITEK
2724 SOUTH PECK RD.
MONROVIA,  CA  91016
Applicant Contact MARLYN SCHEFF
Correspondent
3M UNITEK
2724 SOUTH PECK RD.
MONROVIA,  CA  91016
Correspondent Contact MARLYN SCHEFF
Regulation Number872.3750
Classification Product Code
DYH  
Subsequent Product Codes
DYW   EJF  
Date Received02/06/2002
Decision Date 04/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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