Device Classification Name |
anoscope and accessories
|
510(k) Number |
K881469 |
Device Name |
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL |
Applicant |
BAXTER HEALTHCARE CORP. |
P.O. BOX 11150 |
SANTA ANA,
CA
92711
|
|
Applicant Contact |
BRUCE KRATTENMAKER |
Correspondent |
BAXTER HEALTHCARE CORP. |
P.O. BOX 11150 |
SANTA ANA,
CA
92711
|
|
Correspondent Contact |
BRUCE KRATTENMAKER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/07/1988 |
Decision Date | 09/12/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|