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FDA 510(k) Application Details - K063302
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K063302
Device Name
Unit, Operative Dental
Applicant
SHANGHAI DENTAL INSTRUMENT FACTORY
REGULATORY TECHNOLOGY SERVICES
1394 25TH STREET, NW
BUFFALO, MN 55313 US
Other 510(k) Applications for this Company
Contact
MARK JOB
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
11/01/2006
Decision Date
11/15/2006
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
Y
Expedited Review
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