Device Classification Name |
Catheter, Retention Type
|
510(k) Number |
K770408 |
Device Name |
KARAYA GUM POWDER, OSTOMY |
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 | 876.5980
|
Classification Product Code |
|
Date Received | 03/04/1977 |
Decision Date | 03/15/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|