Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K201863
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K201863
Device Name
Marker, Radiographic, Implantable
Applicant
SOMATEX Medical Technologies GmbH
Hohenzollerndamm 150/151
Berlin 14199 DE
Other 510(k) Applications for this Company
Contact
David Vasmer
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
07/06/2020
Decision Date
02/18/2021
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