Device Classification Name |
cement, stomal appliance, ostomy
|
510(k) Number |
K761319 |
Device Name |
KARAYA GUM PRODUCTS - PROCESS CHANGE |
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 | 12/27/1976 |
Decision Date | 02/15/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|