Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K840854 |
Device Name |
MEDICAL LASER ENDOCOAGULATOR 5K |
Applicant |
HGM, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HGM, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 02/24/1984 |
Decision Date | 04/02/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|