Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K926464 |
Device Name |
L.C.S.3000 |
Applicant |
CRYODYNE TECHNOLOGIES, INC. |
C/O STIEFEL LABORATORIES, INC. |
OAK HILL,
NY
12460
|
|
Applicant Contact |
WILLIAM A CARR |
Correspondent |
CRYODYNE TECHNOLOGIES, INC. |
C/O STIEFEL LABORATORIES, INC. |
OAK HILL,
NY
12460
|
|
Correspondent Contact |
WILLIAM A CARR |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 12/24/1992 |
Decision Date | 08/24/1993 |
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
|
|
|