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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 K983029
Device Name POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001
Applicant
Tpc Advanced Technology, Inc.
181 40 Smokesignal Dr.
San Diego,  CA  92127
Applicant Contact CAROL PATTERSON
Correspondent
Tpc Advanced Technology, Inc.
181 40 Smokesignal Dr.
San Diego,  CA  92127
Correspondent Contact CAROL PATTERSON
Regulation Number872.4850
Classification Product Code
ELC  
Date Received08/31/1998
Decision Date 01/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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