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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K073319
Device Name STATMATIC 31 HANDPIECE MAINTENANCE UNIT
Applicant
Scican , Ltd.
1440 Don Mills Rd.
Toronto,  CA M3B 3P9
Applicant Contact BRENDA MURPHY
Correspondent
Scican , Ltd.
1440 Don Mills Rd.
Toronto,  CA M3B 3P9
Correspondent Contact BRENDA MURPHY
Regulation Number872.4200
Classification Product Code
EFB  
Date Received11/26/2007
Decision Date 02/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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