STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS


Device Classification Name

marker, radiographic, implantable

510(k) Number K081085
Device Name STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
Applicant
SENORX, INC.
11 columbia
aliso viejo, 
CA 
92656

Applicant Contact eben gordon
Correspondent
SENORX, INC.
11 columbia
aliso viejo, 
CA 
92656

Correspodent Contact eben gordon
Regulation Number 878.4300
Classification Product Code
NEU  
Date Received 04/16/2008
Decision Date 08/01/2008
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