MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K030049
Device Name MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
Original Applicant
RUBICOR MEDICAL, INC.
25 hartford ave.
san carlos, 
CA 
94070

Original Contact robert j chin
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 01/06/2003
Decision Date 01/29/2003
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

Recalls CDRH Recalls