ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K111859
Device Name ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
Applicant
GALIL MEDICAL INC.
63 chicory ct.
lake jackson, 
TX 
77566

Applicant Contact amy mckinney
Correspondent
GALIL MEDICAL INC.
63 chicory ct.
lake jackson, 
TX 
77566

Correspodent Contact amy mckinney
Regulation Number 878.4350
Classification Product Code
GEH  
Date Received 06/30/2011
Decision Date 10/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No