Device Classification Name |
Device, Surgical, Cryogenic
|
510(k) Number |
K050272 |
Device Name |
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS |
Applicant |
CRYOMEDICAL INSTRUMENTS, LTD. |
GROVE WAY |
MANSFIELD WOODHOUSE |
MANSFIELD,
GB
NG19 8BW
|
|
Applicant Contact |
GARETH COPPING |
Correspondent |
CRYOMEDICAL INSTRUMENTS, LTD. |
GROVE WAY |
MANSFIELD WOODHOUSE |
MANSFIELD,
GB
NG19 8BW
|
|
Correspondent Contact |
GARETH COPPING |
Regulation Number | 882.4250
|
Classification Product Code |
|
Date Received | 02/04/2005 |
Decision Date | 03/24/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|