Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K113860 |
Device Name |
VISUAL-ICE CRYOABLATION SYSTEM |
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
|
|
Correspondent Contact |
AMY MCKINNEY |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 12/30/2011 |
Decision Date | 03/12/2012 |
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
|
Recalls |
CDRH Recalls
|