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FDA 510(k) Application Details - K040529
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K040529
Device Name
Unit, Operative Dental
Applicant
SATELEC
70 WALNUT ST.
WELLESLEY, MA 02481 US
Other 510(k) Applications for this Company
Contact
JEAN-LUC BOULNOIS
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/01/2004
Decision Date
08/19/2004
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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