MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM


Device Classification Name

instrument, biopsy

510(k) Number K030472
Device Name MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
Applicant
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati, 
OH 
45242 -2839

Applicant Contact michael j crader
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati, 
OH 
45242 -2839

Correspodent Contact michael j crader
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 02/12/2003
Decision Date 10/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No