Device Classification Name |
catheter, urological
|
510(k) Number |
K010339 |
Device Name |
ENDOCARE PERCUTANEOUS ACCESS SET |
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 | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/05/2001 |
Decision Date | 03/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|