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FDA 510(k) Application Details - K142206
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K142206
Device Name
Unit, Operative Dental
Applicant
Zhuhai Siger Medical Equipment Co., Ltd
Building 2, No.1 Chuangxin Yi Road, Tangjiawan Town
Zhuhai 519000 CN
Other 510(k) Applications for this Company
Contact
Huisheng Wang
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
08/11/2014
Decision Date
03/13/2015
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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