| Device Classification Name |
Tube, Feeding
|
| 510(k) Number |
K913701 |
| Device Name |
MOSS - ANCHOR SET |
| Applicant |
| Moss Medical Products |
| Attorney At Law |
| 277 Broadway, Suite 100 |
|
New York,
NY
10007
|
|
| Applicant Contact |
HARRY A SCHLAKMAN |
| Correspondent |
| Moss Medical Products |
| Attorney At Law |
| 277 Broadway, Suite 100 |
|
New York,
NY
10007
|
|
| Correspondent Contact |
HARRY A SCHLAKMAN |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 08/19/1991 |
| Decision Date | 02/14/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|