Device Classification Name |
catheter, peritoneal dialysis, single use
|
510(k) Number |
K885037 |
Device Name |
AMUKIN 50% - AIRSPRAY(R) |
Applicant |
BERNARD J. COONEY, P.A. |
2 WISCONSIN CIRCLE |
SUITE 706 |
CHEVY CHASE,
MD
20815
|
|
Applicant Contact |
JOANNE OGILVIE |
Correspondent |
BERNARD J. COONEY, P.A. |
2 WISCONSIN CIRCLE |
SUITE 706 |
CHEVY CHASE,
MD
20815
|
|
Correspondent Contact |
JOANNE OGILVIE |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 12/05/1988 |
Decision Date | 10/19/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|