Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K002615 |
Device Name |
SURGICAL SYSTEM WITH CRYOGUIDE |
Applicant |
ENDOCARE, INC. |
7 STUDEBAKER |
IRVINE,
CA
92618
|
|
Applicant Contact |
VINCENT CUTARELLI |
Correspondent |
ENDOCARE, INC. |
7 STUDEBAKER |
IRVINE,
CA
92618
|
|
Correspondent Contact |
VINCENT CUTARELLI |
Regulation Number | 878.4350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/22/2000 |
Decision Date | 11/13/2000 |
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
|