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FDA 510(k) Application Details - K150537
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K150537
Device Name
Implant, Endosseous, Root-Form
Applicant
MEGAGEN IMPLANT CO., LTD
472, HANJANGGUN-RO, JAIN-MYEON
GYEONGSAN-SI 712-852 KR
Other 510(k) Applications for this Company
Contact
Dong Guk Ha
Other 510(k) Applications for this Contact
Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
DZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2015
Decision Date
07/21/2015
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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