Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K860358 |
Device Name |
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) |
Applicant |
HGM, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Applicant Contact |
GREG MCARTHUR |
Correspondent |
HGM, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Correspondent Contact |
GREG MCARTHUR |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 01/30/1986 |
Decision Date | 03/21/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|