BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER


Device Classification Name

marker, radiographic, implantable

510(k) Number K023694
Device Name BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
Original Applicant
BIOPSY SCIENCES, LLC
5582 chalon rd.
yorba linda, 
CA 
92886

Original Contact sharon rockwell
Regulation Number 878.4300
Classification Product Code
NEU  
Date Received 11/01/2002
Decision Date 03/17/2003
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