The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Trimedyne Model 1210 Omnipulse Laser System.
Device ID | K905708 |
510k Number | K905708 |
Device Name: | TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
Contact | Merritt M Girgis |
Correspondent | Merritt M Girgis TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-21 |
Decision Date | 1991-03-28 |