Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K925124 |
Device Name |
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST |
Applicant |
TRIMEDYNE, INC. |
47201 LAKEVIEW BLVD. |
P.O. BOX 5120 |
FREMONT,
CA
94537
|
|
Applicant Contact |
PAUL S KRAMSKY |
Correspondent |
TRIMEDYNE, INC. |
47201 LAKEVIEW BLVD. |
P.O. BOX 5120 |
FREMONT,
CA
94537
|
|
Correspondent Contact |
PAUL S KRAMSKY |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 10/13/1992 |
Decision Date | 03/01/1994 |
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
|