Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K002308 |
Device Name |
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A |
Applicant |
TRIMEDYNE, INC. |
2801 BARRANCA RD. |
P.O. BOX 57001 |
IRVINE,
CA
92619 -7001
|
|
Applicant Contact |
SUSAN H GAMBLE |
Correspondent |
TRIMEDYNE, INC. |
2801 BARRANCA RD. |
P.O. BOX 57001 |
IRVINE,
CA
92619 -7001
|
|
Correspondent Contact |
SUSAN H GAMBLE |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/28/2000 |
Decision Date | 12/20/2000 |
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
|