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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 K071891
Device Name STATIS DENTAL HANDPIECES
Applicant
SCICAN LTD.
1440 DON MILLS RD.
TORONTO, ONTARIO,  CA M3B 3P9
Applicant Contact BRENDA MURPHY
Correspondent
SCICAN LTD.
1440 DON MILLS RD.
TORONTO, ONTARIO,  CA M3B 3P9
Correspondent Contact BRENDA MURPHY
Regulation Number872.4200
Classification Product Code
EFB  
Date Received07/09/2007
Decision Date 09/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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