Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K112716
Device Classification Name
Bone Grafting Material, Synthetic
More FDA Info for this Device
510(K) Number
K112716
Device Name
Bone Grafting Material, Synthetic
Applicant
GENOSS CO., LTD.
1F GYEONGGI R&D CENTER
906-5 IUI-DONG
SUWON-SI YEONGTONG-GU, GYEONGG 443-270 KR
Other 510(k) Applications for this Company
Contact
SUNGWON LEE
Other 510(k) Applications for this Contact
Regulation Number
872.3930
More FDA Info for this Regulation Number
Classification Product Code
LYC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2011
Decision Date
01/17/2012
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact