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FDA 510(k) Application Details - K163414
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K163414
Device Name
Scaler, Ultrasonic
Applicant
NANNING VV DENTAL CO., LTD.
4th floor,North Bld. No.1 , Zhengxin Tech Zone, No. 2,
Gaoxin 7 Rd.
Nan ning 530007 CN
Other 510(k) Applications for this Company
Contact
Liang chaojun
Other 510(k) Applications for this Contact
Regulation Number
872.4850
More FDA Info for this Regulation Number
Classification Product Code
ELC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2016
Decision Date
11/21/2017
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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