Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K031292 |
Device Name |
MODIFICATION TO FOSSA URETERAL STONE SWEEPER |
Applicant |
FOSSA MEDICAL, INC. |
5 WHITCOMB AVE. |
AYER,
MA
01432
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
FOSSA MEDICAL, INC. |
5 WHITCOMB AVE. |
AYER,
MA
01432
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 876.4620
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/23/2003 |
Decision Date | 05/22/2003 |
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
|
|
|