Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K011074 |
Device Name |
CRYOCARE SURGICAL SYSTEM |
Applicant |
ENDOCARE, INC. |
7 STUDEBAKER |
IRVINE,
CA
92618
|
|
Applicant Contact |
VINCENT CUTARTELLI |
Correspondent |
ENDOCARE, INC. |
7 STUDEBAKER |
IRVINE,
CA
92618
|
|
Correspondent Contact |
VINCENT CUTARTELLI |
Regulation Number | 878.4350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/09/2001 |
Decision Date | 01/25/2002 |
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
|
Recalls |
CDRH Recalls
|
|
|