Device Classification Name |
System, Irrigation, Urological
|
510(k) Number |
K960787 |
Device Name |
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS |
Applicant |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
MARY-ELLEN SAYDER |
Correspondent |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
MARY-ELLEN SAYDER |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/26/1996 |
Decision Date | 05/14/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|