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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 K033764
Device Name SP NEWTRON MODULE
Applicant
SATELEC
Z.I. DU PHARE, B.P. 216
17, AVENUE GUSTAVE EIFFEL
MERIGNAC CEDEX,  FR 33708
Applicant Contact PASCAL DUPEYRON
Correspondent
SATELEC
Z.I. DU PHARE, B.P. 216
17, AVENUE GUSTAVE EIFFEL
MERIGNAC CEDEX,  FR 33708
Correspondent Contact PASCAL DUPEYRON
Regulation Number872.4850
Classification Product Code
ELC  
Date Received12/02/2003
Decision Date 03/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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