Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K153573
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K153573
Device Name
Plate, Fixation, Bone
Applicant
BIOMEDICAL ENTERPRISES, INC
14785 OMICRON DR., STE 205
SAN ANTONIO, TX 78245 US
Other 510(k) Applications for this Company
Contact
Joe Soward
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2015
Decision Date
08/11/2016
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