ATRICURE CRYO MODULE SYSTEM


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K112072
Device Name ATRICURE CRYO MODULE SYSTEM
Applicant
ATRICURE, INC.
6217 centre park drive
west chester, 
OH 
45069

Applicant Contact james l lucky
Regulation Number 878.4350
Classification Product Code
GEH  
Date Received 07/20/2011
Decision Date 08/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No