Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K982055 |
Device Name |
ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 |
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 |
|
Subsequent Product Code |
|
Date Received | 06/11/1998 |
Decision Date | 09/08/1998 |
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
|
|
|