Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K040760 |
Device Name |
MODIFICATION TO URETERAL STENT |
Applicant |
APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
CHERYL BLAKE |
Correspondent |
APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Correspondent Contact |
ANDREW NGUYEN |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 03/25/2004 |
Decision Date | 10/15/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|