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FDA 510(k) Application Details - K033764
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K033764
Device Name
Scaler, Ultrasonic
Applicant
SATELEC
Z.I. DU PHARE, B.P. 216
17, AVENUE GUSTAVE EIFFEL
MERIGNAC CEDEX 33708 FR
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Contact
PASCAL DUPEYRON
Other 510(k) Applications for this Contact
Regulation Number
872.4850
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Classification Product Code
ELC
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More FDA Info for this Product Code
Date Received
12/02/2003
Decision Date
03/01/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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