Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K962632 |
Device Name |
OMNIPULSE/OMNIPULSE-MAX |
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 | 07/05/1996 |
Decision Date | 01/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|