Device Classification Name |
Laser, Surgical, Gynecologic
|
510(k) Number |
K862227 |
Device Name |
MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN |
Applicant |
HGM, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Applicant Contact |
LANDUCCI, M.D. |
Correspondent |
HGM, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Correspondent Contact |
LANDUCCI, M.D. |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 06/11/1986 |
Decision Date | 08/19/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|