ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K110946
Device Name ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
Applicant
GALIL MEDICAL LTD.
yokneam gate, 1 tavor bldg.
yokneam, 

IL

20692

Applicant Contact lynne davies
Correspondent
GALIL MEDICAL LTD.
yokneam gate, 1 tavor bldg.
yokneam, 

IL

20692

Correspodent Contact lynne davies
Regulation Number 878.4350
Classification Product Code
GEH  
Date Received 04/04/2011
Decision Date 06/21/2011
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