Device Classification Name |
garment, protective, for incontinence
|
510(k) Number |
K880455 |
Device Name |
AT EASE ADULT DIAPER |
Applicant |
HOSPITAL SPECIALTY CO. |
7501 CARNEGIE AVE. |
CLEVELAND,
OH
44103 -4896
|
|
Applicant Contact |
ROBERT A MAY |
Correspondent |
HOSPITAL SPECIALTY CO. |
7501 CARNEGIE AVE. |
CLEVELAND,
OH
44103 -4896
|
|
Correspondent Contact |
ROBERT A MAY |
Regulation Number | 876.5920
|
Classification Product Code |
|
Date Received | 02/02/1988 |
Decision Date | 04/14/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|