Device Classification Name |
Unit, Cryosurgical, Accessories
|
510(k) Number |
K101333 |
Device Name |
CRYOCARE CS SURGICAL SYSTEM |
Applicant |
ENDOCARE, INC. |
9825 SPECTRUM DRIVE |
BLDG 2 |
AUSTIN,
TX
78717
|
|
Applicant Contact |
DEVONNE PAVLAK |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 05/12/2010 |
Decision Date | 06/14/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|