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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 K150129
Device Name AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
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 Received01/21/2015
Decision Date 05/28/2015
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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