Device Classification Name |
source, abortion unit, vacuum
|
510(k) Number |
K890787 |
Device Name |
O-020 LASER INDIRECT OPHTHALMOSCOPE |
Applicant |
HGM MEDICAL LASER SYSTEMS, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Applicant Contact |
BILL PAPWORTH |
Correspondent |
HGM MEDICAL LASER SYSTEMS, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Correspondent Contact |
BILL PAPWORTH |
Regulation Number | 884.5070
|
Classification Product Code |
|
Date Received | 02/15/1989 |
Decision Date | 03/24/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|