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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 K033705
Device Name BOBCAT PRO SCALER SYSTEM, MODEL G-130
Applicant
Dentsply International
570 W. College Ave.
P.O. Box 872
York,  PA  17404
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply International
570 W. College Ave.
P.O. Box 872
York,  PA  17404
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.4850
Classification Product Code
ELC  
Date Received11/25/2003
Decision Date 12/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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