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FDA 510(k) Application Details - K200189
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K200189
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Shinhung MST Co., Ltd.
110-2, Donghwagong-Ro Munmak-Eup
Wonju Si 220-801 KR
Other 510(k) Applications for this Company
Contact
Jae Soo Song
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/27/2020
Decision Date
02/26/2020
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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