| 510(k) Number |
K827847 |
| Device Name |
ARGON FIBER OPTIC CATHETER |
| Applicant |
| Hgm, Inc. |
| 3959 W. 1820 S. |
|
Salt Lake City,
UT
84104
|
|
| Correspondent |
| Hgm, Inc. |
| 3959 W. 1820 S. |
|
Salt Lake City,
UT
84104
|
|
| Date Received | 11/04/1982 |
| Decision Date | 01/03/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|