Device Classification Name |
Catheter, Ureteral, Gastro-Urology
|
510(k) Number |
K033368 |
Device Name |
FOSSA URETERAL OPEN LUMEN STENT |
Applicant |
FOSSA MEDICAL, INC. |
580 HARRISON AVE., 4TH FL. |
BOSTON,
MA
02118
|
|
Applicant Contact |
GLORIA KOLB |
Correspondent |
FOSSA MEDICAL, INC. |
580 HARRISON AVE., 4TH FL. |
BOSTON,
MA
02118
|
|
Correspondent Contact |
GLORIA KOLB |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 10/21/2003 |
Decision Date | 11/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|