The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Switchable Tip System.
Device ID | K923191 |
510k Number | K923191 |
Device Name: | SWITCHABLE TIP SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine, CA 92714 -5114 |
Contact | Paul S Kramsky |
Correspondent | Paul S Kramsky TRIMEDYNE, INC. 2801 BARRANCA RD. Irvine, CA 92714 -5114 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-30 |
Decision Date | 1993-03-31 |