Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K851405 |
Device Name |
TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 |
Applicant |
TRIMEDYNE, INC. |
1815 EAST CARNEGIE AVE. |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
HANY HUSSEIN |
Correspondent |
TRIMEDYNE, INC. |
1815 EAST CARNEGIE AVE. |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
HANY HUSSEIN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 04/09/1985 |
Decision Date | 10/07/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|