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FDA 510(k) Application Details - K131289
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K131289
Device Name
Plate, Bone
Applicant
MEGAGEN IMPLANT CO., LTD
325 N PUENTE ST. UNIT B
BREA, CA 92821 US
Other 510(k) Applications for this Company
Contact
APRIL LEE
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2013
Decision Date
09/25/2013
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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