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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 K051547
Device Name POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30
Applicant
Tpc Advanced Technology, Inc.
17588 E. Rowland St.
City Of Industry,  CA  91748
Applicant Contact SCOTT BECKLEY
Correspondent
Tpc Advanced Technology, Inc.
17588 E. Rowland St.
City Of Industry,  CA  91748
Correspondent Contact SCOTT BECKLEY
Regulation Number872.4850
Classification Product Code
ELC  
Date Received06/13/2005
Decision Date 07/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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