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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 K010195
Device Name PREMIER ULTRASONIC SCALER AND INSERTS
Applicant
Premier Dental Products Co.
3600 Horizon Dr.
P.O. Box 61574
King Of Prussia,  PA  19406
Applicant Contact WILLIAN FREZEL
Correspondent
Premier Dental Products Co.
3600 Horizon Dr.
P.O. Box 61574
King Of Prussia,  PA  19406
Correspondent Contact WILLIAN FREZEL
Regulation Number872.4850
Classification Product Code
ELC  
Date Received01/22/2001
Decision Date 04/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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