SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM


Device Classification Name

marker, radiographic, implantable

510(k) Number K072913
Device Name SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
Applicant
SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY
6100 technology center dr.
indianapolis, 
IN 
46278

Applicant Contact paula a gray
Correspondent
SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY
6100 technology center dr.
indianapolis, 
IN 
46278

Correspodent Contact paula a gray
Regulation Number 878.4300
Classification Product Code
NEU  
Date Received 10/12/2007
Decision Date 01/04/2008
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