Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K903418 |
Device Name |
LATERALASE TM |
Applicant |
TRIMEDYNE, INC. |
1311 VALENCIA AVE. |
TUSTIN,
CA
92680
|
|
Applicant Contact |
MERRITT GIRGIS |
Correspondent |
TRIMEDYNE, INC. |
1311 VALENCIA AVE. |
TUSTIN,
CA
92680
|
|
Correspondent Contact |
MERRITT GIRGIS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/31/1990 |
Decision Date | 06/24/1991 |
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
|