Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K904421 |
Device Name |
CMS ONCOPROBE (TM) |
Applicant |
CRYOMEDICAL SCIENCES, INC. |
THREE BETHESDA METRO CDENTER |
SUITE 700 |
BETHESDA,
MD
20814
|
|
Applicant Contact |
FINKELSTIEN |
Correspondent |
CRYOMEDICAL SCIENCES, INC. |
THREE BETHESDA METRO CDENTER |
SUITE 700 |
BETHESDA,
MD
20814
|
|
Correspondent Contact |
FINKELSTIEN |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 09/27/1990 |
Decision Date | 04/08/1991 |
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
|
|
|