EPICOR MEDICAL ABLATION SYSTEM


Device Classification Name

system, ablation, ultrasound and accessories

510(k) Number K022894
Device Name EPICOR MEDICAL ABLATION SYSTEM
Original Applicant
EPICOR MEDICAL, INC.
240 santa ana court
sunnyvale, 
CA 
94085

Original Contact kathi guerrant
Regulation Number 878.4400
Classification Product Code
NTB  
Subsequent Product Code
OCL  
Date Received 09/03/2002
Decision Date 02/26/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No