Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K032333 |
Device Name |
CRYOCARE CS SURGICAL SYSTEM |
Applicant |
ENDOCARE, INC. |
201 TECHNOLOGY DR. |
IRVINE,
CA
92618
|
|
Applicant Contact |
EBEN GORDON |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
LAURA DANIELSON |
Regulation Number | 878.4350
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/29/2003 |
Decision Date | 08/12/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|