| 510(k) Number |
K853741 |
| Device Name |
INDONTINENCE PAD |
| Applicant |
| Beghin_Say Intl., Inc. |
| P.O. Box 6236 |
|
Lakeland,
FL
33807
|
|
| Applicant Contact |
SNIDER |
| Correspondent |
| Beghin_Say Intl., Inc. |
| P.O. Box 6236 |
|
Lakeland,
FL
33807
|
|
| Correspondent Contact |
SNIDER |
| Date Received | 09/06/1985 |
| Decision Date | 11/14/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|