Device Classification Name |
staple, implantable
|
510(k) Number |
K001807 |
Device Name |
TISSUE MARKER |
Applicant |
ADVANCED UROSCIENCE, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Applicant Contact |
KAREN E PETERSON |
Correspondent |
ADVANCED UROSCIENCE, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Correspondent Contact |
KAREN E PETERSON |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 06/15/2000 |
Decision Date | 05/03/2001 |
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
|
|
|