Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K892237 |
Device Name |
THE FERN CRYOPROBE |
Applicant |
CRYOGENIC INSTRUMENTS & EQUIPMENT LTD. |
P.O. BOX 1 |
STRATHAVEN LANARKSHIRE |
SCOTLAND ML10 6SN,
GB
|
|
Applicant Contact |
W. M SELFRIDGE |
Correspondent |
CRYOGENIC INSTRUMENTS & EQUIPMENT LTD. |
P.O. BOX 1 |
STRATHAVEN LANARKSHIRE |
SCOTLAND ML10 6SN,
GB
|
|
Correspondent Contact |
W. M SELFRIDGE |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 04/04/1989 |
Decision Date | 07/25/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|