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FDA 510(k) Application Details - K000941
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K000941
Device Name
Unit, Operative Dental
Applicant
STERLTECH, INC.
60 LAKESIDE BLVD. WEST
WATERBURY, CT 06708 US
Other 510(k) Applications for this Company
Contact
JOHN R NOLL
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
03/23/2000
Decision Date
04/06/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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