Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K141725
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K141725
Device Name
Filler, Bone Void, Calcium Compound
Applicant
BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO, L
7 LIBERTY RIDGE ROAD
BASKING RIDGE, NJ 07920 US
Other 510(k) Applications for this Company
Contact
HELEN CUI
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
06/26/2014
Decision Date
07/09/2015
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