TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560


Device Classification Name

marker, radiographic, implantable

510(k) Number K073095
Device Name TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560
Applicant
SOMATEX MEDICAL TECHNOLOGIES GMBH
1480 cambridge street
cambridge, 
MA 
02139

Applicant Contact susanne raab
Correspondent
SOMATEX MEDICAL TECHNOLOGIES GMBH
1480 cambridge street
cambridge, 
MA 
02139

Correspodent Contact susanne raab
Regulation Number 878.4300
Classification Product Code
NEU  
Date Received 11/01/2007
Decision Date 03/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No