TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC


Device Classification Name

marker, radiographic, implantable

510(k) Number K111692
Device Name TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
Applicant
SOMATEX MEDICAL TECHNOLOGIES GMBH
unterer winkel 3
wurmlingen, 

DE

78573

Applicant Contact harald jung
Correspondent
SOMATEX MEDICAL TECHNOLOGIES GMBH
unterer winkel 3
wurmlingen, 

DE

78573

Correspodent Contact harald jung
Regulation Number 878.4300
Classification Product Code
NEU  
Date Received 06/16/2011
Decision Date 11/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No