Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K964336 |
Device Name |
CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 |
Applicant |
CRYOMEDICAL SCIENCES, INC. |
1300 PICCARD DR. |
ROCKVILLE,
MD
20850
|
|
Applicant Contact |
RICHARD J REINHART |
Correspondent |
CRYOMEDICAL SCIENCES, INC. |
1300 PICCARD DR. |
ROCKVILLE,
MD
20850
|
|
Correspondent Contact |
RICHARD J REINHART |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 10/31/1996 |
Decision Date | 03/20/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|