Device Classification Name |
Collector, Ostomy
|
510(k) Number |
K813080 |
Device Name |
WOUND DRAINAGE MANAGEMENT SYSTEMS |
Applicant |
HOWMEDICA CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HOWMEDICA CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 11/02/1981 |
Decision Date | 11/17/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|