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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K070866
Device Name ASC-12 PIEZOELECTRIC SCALER
Applicant
Aseptico, Inc.
8333 216th St. SE
Woodinville,  WA  98072
Applicant Contact GRANT RAMALEY
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number872.4850
Classification Product Code
ELC  
Date Received03/29/2007
Decision Date 04/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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