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FDA 510(k) Application Details - K150798
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K150798
Device Name
Handpiece, Air-Powered, Dental
Applicant
CODENT TECHNICAL INDUSTRY CO., LTD.
5F., No.90, Luke 5th Rd., Luzhu District
SOUTHERN TAIWAN SCIENCE PARK
Kaohsiung City 82151 TW
Other 510(k) Applications for this Company
Contact
Chin-Ting Wen
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
03/26/2015
Decision Date
04/24/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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