BIOPSY SITE MARKER


Device Classification Name

clip, implantable

510(k) Number K011402
Device Name BIOPSY SITE MARKER
Original Applicant
SENORX, INC.
11 columbia, suite a
aliso viejo, 
CA 
92656

Original Contact amy boucly
Regulation Number 878.4300
Classification Product Code
FZP  
Date Received 05/07/2001
Decision Date 07/16/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No