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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K103399
Device Name GENERAL DENISTRY MOTOR
Applicant
Aseptico, Inc.
8333 216th St. SE
Woodinville,  WA  98072
Applicant Contact CHERIE TREGONING
Correspondent
Aseptico, Inc.
8333 216th St. SE
Woodinville,  WA  98072
Correspondent Contact CHERIE TREGONING
Regulation Number872.4200
Classification Product Code
EKX  
Date Received11/19/2010
Decision Date 02/28/2011
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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