Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K030303 |
Device Name |
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE |
Applicant |
CRYOCATH TECHNOLOGIES, INC. |
16771 CHEMIN STE MARIE |
KIRKLAND,
CA
H9H 5H3
|
|
Applicant Contact |
JEAN-PIERRE DESMARAIS |
Correspondent |
CRYOCATH TECHNOLOGIES, INC. |
16771 CHEMIN STE MARIE |
KIRKLAND,
CA
H9H 5H3
|
|
Correspondent Contact |
JEAN-PIERRE DESMARAIS |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 01/29/2003 |
Decision Date | 04/29/2003 |
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
|