| Device Classification Name |
Cushion, Hemorrhoid
|
| 510(k) Number |
K864470 |
| Device Name |
HEMOREST(TM) |
| Applicant |
| Health Aid Products |
| 5881 NW 151st St. |
| Suite 101a |
|
Miami Lakes,
FL
33014
|
|
| Applicant Contact |
PAUL SALVER |
| Correspondent |
| Health Aid Products |
| 5881 NW 151st St. |
| Suite 101a |
|
Miami Lakes,
FL
33014
|
|
| Correspondent Contact |
PAUL SALVER |
| Classification Product Code |
|
| Date Received | 11/12/1986 |
| Decision Date | 06/23/1987 |
| 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
|
|
|