Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K890279 |
Device Name |
MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER |
Applicant |
TRIMEDYNE, INC. |
1311 VALENCIA AVE. |
TUSTIN,
CA
92680
|
|
Applicant Contact |
KIMBERLEY DONEY |
Correspondent |
TRIMEDYNE, INC. |
1311 VALENCIA AVE. |
TUSTIN,
CA
92680
|
|
Correspondent Contact |
KIMBERLEY DONEY |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/12/1989 |
Decision Date | 02/07/1989 |
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
|