ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY


Device Classification Name

surgical device, for ablation of cardiac tissue

510(k) Number K110913
Device Name ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
Applicant
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
2603 camino ramon
suite 100
san ramon, 
CA 
94583

Applicant Contact tamer ibrahim
Correspondent
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
2603 camino ramon
suite 100
san ramon, 
CA 
94583

Correspodent Contact tamer ibrahim
Regulation Number 878.4400
Classification Product Code
OCL  
Date Received 04/01/2011
Decision Date 09/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No