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FDA 510(k) Application Details - K972026
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K972026
Device Name
Scaler, Ultrasonic
Applicant
SATELEC
70 WALNUT ST.
WELLESLEY, MA 02481 US
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Contact
JACKIE MASSE
Other 510(k) Applications for this Contact
Regulation Number
872.4850
More FDA Info for this Regulation Number
Classification Product Code
ELC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/1997
Decision Date
07/09/1997
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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