Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K170803
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K170803
Device Name
Marker, Radiographic, Implantable
Applicant
Devicor Medical Products, Inc.
300 E-Business Way, Fifth Floor
Cincinnati, OH 45241 US
Other 510(k) Applications for this Company
Contact
Shawna Rose
Other 510(k) Applications for this Contact
Regulation Number
878.4300
More FDA Info for this Regulation Number
Classification Product Code
NEU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/17/2017
Decision Date
06/15/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact