Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K140913
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K140913
Device Name
Filler, Bone Void, Calcium Compound
Applicant
ORIENTAL RESOURCES DEVELOPMENT LIMITED
NO.45 MINSHENG ROAD
DANSHUI TOWN
NEW TAIPEI CITY 251 TW
Other 510(k) Applications for this Company
Contact
MICHAEL LEE
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/10/2014
Decision Date
02/17/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact