Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K992230 |
Device Name |
OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP |
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 |
|
Subsequent Product Codes |
|
Date Received | 07/02/1999 |
Decision Date | 07/12/1999 |
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
|