MODIFICATION TO NEOTHERMIA’S EN-BLOC BIOPSY SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K023413
Device Name MODIFICATION TO NEOTHERMIA’S EN-BLOC BIOPSY SYSTEM
Original Applicant
NEOTHERMIA CORP.
one apple hill suite 316
natick, 
MA 
01760

Original Contact sherrie coval-goldsmith
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Code
KNW  
Date Received 10/11/2002
Decision Date 11/08/2002
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