| 510(k) Number |
K852913 |
| Device Name |
HGM ENDOCOAGULATOR MODEL 20 |
| Applicant |
| Hgm, Inc. |
| 3959 W. 1820 S. |
|
Salt Lake City,
UT
84104
|
|
| Applicant Contact |
JEROME STENEHJEM |
| Correspondent |
| Hgm, Inc. |
| 3959 W. 1820 S. |
|
Salt Lake City,
UT
84104
|
|
| Correspondent Contact |
JEROME STENEHJEM |
| Date Received | 07/11/1985 |
| Decision Date | 09/05/1985 |
| 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
|
|
|