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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 K142124
Device Name AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
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 Received08/04/2014
Decision Date 12/31/2014
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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