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FDA 510(k) Application Details - K093084
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K093084
Device Name
Handpiece, Air-Powered, Dental
Applicant
ROLENCE ENT. INC.
NO.58,FU CHIUN STREET
HSIN CHU CITY 30067 TW
Other 510(k) Applications for this Company
Contact
JEN KE-MIN
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2009
Decision Date
12/16/2009
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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