FDA 510(k) Applications Submitted by SUSAN H GAMBLE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K001676 |
06/01/2000 |
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A |
TRIMEDYNE, INC. |
| K992230 |
07/02/1999 |
OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP |
TRIMEDYNE, INC. |
| K962632 |
07/05/1996 |
OMNIPULSE/OMNIPULSE-MAX |
TRIMEDYNE, INC. |
| K002308 |
07/28/2000 |
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A |
TRIMEDYNE, INC. |
| K992574 |
08/02/1999 |
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A |
TRIMEDYNE, INC. |
| K973172 |
08/25/1997 |
RESPOSABLE BARE FIBERS |
TRIMEDYNE, INC. |
| K954597 |
10/03/1995 |
RIGHT ANGLE LASER FIBERS |
TRIMEDYNE, INC. |
| K964585 |
11/15/1996 |
RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) |
TRIMEDYNE, INC. |
| K013974 |
12/03/2001 |
RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A |
TRIMEDYNE, INC. |
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