Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K051052 |
Device Name |
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) |
Applicant |
GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
GALIL MEDICAL LTD. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 878.4350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/25/2005 |
Decision Date | 05/06/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|